Indacaterol

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Benjamin Kramer - One of the best experts on this subject based on the ideXlab platform.

  • efficacy and safety of Indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six asian areas including japan a 12 week placebo controlled study
    Respirology, 2012
    Co-Authors: Masaharu Kinoshita, Benjamin Kramer, Liang Wen Hang, Masakazu Ichinose, Motoi Hosoe, Naoko Okino, Niyati Prasad, Yoshinosuke Fukuchi
    Abstract:

    Background and objective:  The efficacy and safety of Indacaterol, a novel inhaled once daily ultra long-acting β2-agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of Indacaterol in Japan. Methods:  Moderate-to-severe COPD patients were randomized to Indacaterol 150 µg, Indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV1 (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated. Results:  A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV1% predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV1 at week 12 for Indacaterol 150 µg, Indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for Indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both Indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both Indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: −4.8 and −5.7 units). Adverse events for Indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported. Conclusions:  Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.

  • efficacy and tolerability of Indacaterol 75 μg once daily in patients aged 40 years with chronic obstructive pulmonary disease results from 2 double blind placebo controlled 12 week studies
    Clinical Therapeutics, 2011
    Co-Authors: Edward Kerwin, David Lawrence, Cheryl Lassen, Mark H Gotfried, Benjamin Kramer
    Abstract:

    Abstract Background Indacaterol is the first once-daily, long-acting, inhaled β 2 -agonist bronchodilator for maintenance treatment of chronic obstructive pulmonary disease (COPD). Two studies (previously reported in a Congress abstract) were performed in 2010 to provide efficacy and tolerability data to support the application for approval in the United States of Indacaterol 75 μg once daily, a dose lower than that previously investigated in most studies. Objective The primary objective was to evaluate the efficacy of Indacaterol 75 μg once daily in terms of 24-hour post-dose (“trough”) forced expiratory volume in the first second of respiration (FEV 1 ) compared with placebo after 12 weeks of treatment. Methods Patients with moderate to severe COPD were randomized to receive double-blind treatment with Indacaterol 75 μg once daily (n = 163 and 159) or placebo (n = 160 and 159) for 12 weeks. In addition to trough FEV 1 after 12 weeks, rescue albuterol use, health status (St. George's Respiratory Questionnaire [SGRQ]), and tolerability were evaluated. Clinically relevant differences between active and placebo treatments were defined as ≥120 mL for trough FEV 1 and a decrease of ≥4 units in SGRQ total score. Results Of patients enrolled in the 2 studies, 54% were men, and 90% and 94% were white, with mean age 64 and 61 years. Mean duration of COPD was 7 years; smoking history was 52 pack-years; and 45% and 37% of patients were receiving inhaled corticosteroid therapy. At week 12, Indacaterol demonstrated clinically relevant bronchodilator efficacy, increasing trough FEV 1 by ≥120 mL versus placebo ( P P P P ≤ 0.01). Adverse events were reported for 49% and 45% of patients receiving Indacaterol therapy, and for 46% and 41% receiving placebo. Conclusions Compared with placebo, Indacaterol 75 μg once daily provided statistically significant and clinically relevant 24-hour bronchodilation and was well tolerated. In patients receiving Indacaterol, the reduction in rescue albuterol use was statistically significant. Changes in health status also were statistically significant compared with placebo, although the differences of 3.6 and 3.8 units were below the predefined 4-unit level of clinical relevance. The results of these studies suggest that Indacaterol 75 μg once daily is an effective maintenance treatment in patients with moderate to severe COPD. ClinicalTrials.gov identifiers: NCT01072448 and NCT01068600 .

  • blinded 12 week comparison of once daily Indacaterol and tiotropium in copd
    European Respiratory Journal, 2011
    Co-Authors: Roland Buhl, Cheryl Lassen, Benjamin Kramer, Michelle Henley, L J Dunn, C Disdier, C Amos, Intensity Study Investigators
    Abstract:

    Two, once daily ( q.d. ) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β 2 -agonist Indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with Indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on “trough” (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 versus 1.43; p versus 39.2; p versus -3.0), and were significantly more likely to achieve clinically relevant improvements in these end-points (Indacaterol versus tiotropium odds ratios of 1.49 for TDI and 1.43 for SGRQ, both p Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, Indacaterol provided significantly greater improvements in clinical outcomes.

  • safety of Indacaterol in the treatment of patients with copd
    International Journal of Chronic Obstructive Pulmonary Disease, 2011
    Co-Authors: James F Donohue, Oliver Kornmann, David Lawrence, Cheryl Lassen, Dave Singh, Benjamin Kramer
    Abstract:

    PURPOSE: Pooled data were analyzed to evaluate the safety and tolerability of Indacaterol, a once-daily inhaled long-acting ?(2)-agonist for chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind Indacaterol 75 ?g (n = 449), 150 ?g (n = 2611), 300 ?g (n = 1157), or 600 ?g once daily (n = 547); formoterol 12 ?g twice daily (n = 556); salmeterol 50 ?g twice daily (n = 895); placebo (n = 2012); or tiotropium 18 ?g once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. RESULTS: The commonest adverse events with Indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were < 1 for all Indacaterol doses. Notable values for vital signs and measures of systemic ?(2)-adrenoceptor activity were rare with Indacaterol. The number of deaths adjusted per patient-year was lower with Indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008). CONCLUSION: Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.

  • efficacy of Indacaterol in the treatment of patients with copd
    Primary Care Respiratory Journal, 2011
    Co-Authors: Paul W Jones, David Lawrence, C Vogelmeier, Neil Barnes, Benjamin Kramer
    Abstract:

    : Effective bronchodilation is an important part of the management of patients with chronic obstructive pulmonary disease (COPD) and can improve breathlessness and ability to undertake physical activities. Indacaterol is a new once-daily, long-acting inhaled bronchodilator for COPD. We review here the efficacy of Indacaterol as a bronchodilator, including its impact upon symptoms and health status. The evidence reviewed comprises four placebo-controlled clinical studies of Indacaterol treatment, three of which included treatment arms with one of the other long-acting inhaled bronchodilators (once-daily tiotropium or twice-daily salmeterol or formoterol), in 4,833 patients with moderate-to-severe COPD. Indacaterol had a bronchodilator effect significantly greater than formoterol and salmeterol, and similar to tiotropium. Its effect on symptoms and health status was similar or significantly greater than the other bronchodilators. The safety profile was similar to placebo. Once-daily Indacaterol is an effective and beneficial maintenance bronchodilator treatment for patients with moderate-to-severe COPD.

Roger Owen - One of the best experts on this subject based on the ideXlab platform.

  • Comparative Effectiveness Research/Health Technology Assessment Efficacy of Once-Daily Indacaterol Relative to Alternative Bronchodilators in COPD: A Patient-Level Mixed Treatment Comparison
    2020
    Co-Authors: Shannon Cope, Roger Owen, Gorana Capkun-niggli, Rupert Gale, Cheryl Lassen, Gert J.d. Bergman, Jeroen P. Jansen
    Abstract:

    Objective: Indacaterol was evaluated versus placebo, formoterol, and salmeterol in randomized controlled trials. No direct comparisons, however, are available for Indacaterol 150 g with formoterol or Indacaterol 300 g with salmeterol. Indacaterol trial evidence was synthesized to provide coherent estimates of Indacaterol 150 g and Indacaterol 300 g relative to formoterol, salmeterol, and tiotropium. Methods: Four randomized controlled trials were combined with Bayesian mixed treatment comparisons by using individual patientlevel data. End points of interest were trough forced expiratory volume in 1 second (FEV1), St. George’s Respiratory Questionnaire (SGRQ) total score and response (4 points), and Transition Dyspnea Index total score and response (1 point). Results: Indacaterol 150 g demonstrated a higher FEV1 than did formoterol at 12 weeks and 6 months (0.10 L difference; 95% credible interval [CrI] 0.06 – 0.14), as did Indacaterol 300 g versus salmeterol (0.06 L difference at 12 weeks; CrI 0.02– 0.10; 0.06 L at 6 months; CrI 0.02– 0.11). Regarding SGRQ, Indacaterol 150 g demonstrated a comparable proportion of responders versus formoterol, as did Indacaterol 300 g versus salmeterol. In comparison to tiotropium, Indacaterol 150 g demonstrated a greater proportion of responders (odds ratio 1.52 at 12 weeks; CrI 1.15–2.00). For Transition Dyspnea Index, Indacaterol 150 g and formoterol showed a similar response. Indacaterol 300 g was more efficacious than salmeterol (odds ratio 1.65 at 12 weeks; CrI 1.16 – 2.34). Overall, Indacaterol 150 g showed the greatest efficacy for SGRQ and Indacaterol 300 g for FEV1 and Transition Dyspnea Index. Conclusion: Indacaterol is expected to be comparable to formoterol, salmeterol, and tiotropium, providing higher FEV1 than formoterol and salmeterol and greater improvement in the SGRQ total score than tiotropium. Indacaterol 150 g provided comparable improvement in dyspnea, while Indacaterol 300 g demonstrated the greatest response

  • Efficacy of Once-Daily Indacaterol Relative to Alternative Bronchodilators in COPD: A Patient-Level Mixed Treatment Comparison
    Value in Health, 2012
    Co-Authors: Shannon Cope, Roger Owen, Gorana Capkun-niggli, Rupert Gale, Cheryl Lassen, Gert J.d. Bergman, Mario J.n.m. Ouwens, Jeroen P. Jansen
    Abstract:

    Abstract Objective Indacaterol was evaluated versus placebo, formoterol, and salmeterol in randomized controlled trials. No direct comparisons, however, are available for Indacaterol 150 μg with formoterol or Indacaterol 300 μg with salmeterol. Indacaterol trial evidence was synthesized to provide coherent estimates of Indacaterol 150 μg and Indacaterol 300 μg relative to formoterol, salmeterol, and tiotropium. Methods Four randomized controlled trials were combined with Bayesian mixed treatment comparisons by using individual patient-level data. End points of interest were trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and response (≥4 points), and Transition Dyspnea Index total score and response (≥1 point). Results Indacaterol 150 μg demonstrated a higher FEV 1 than did formoterol at 12 weeks and 6 months (0.10 L difference; 95% credible interval [CrI] = 0.06–0.14), as did Indacaterol 300 μg versus salmeterol (0.06 L difference at 12 weeks; CrI=0.02–0.10; 0.06 L at 6 months; CrI=0.02–0.11). Regarding SGRQ, Indacaterol 150 μg demonstrated a comparable proportion of responders versus formoterol, as did Indacaterol 300 μg versus salmeterol. In comparison to tiotropium, Indacaterol 150 μg demonstrated a greater proportion of responders (odds ratio=1.52 at 12 weeks; CrI 1.15–2.00). For Transition Dyspnea Index, Indacaterol 150 μg and formoterol showed a similar response. Indacaterol 300 μg was more efficacious than salmeterol (odds ratio=1.65 at 12 weeks; CrI 1.16–2.34). Overall, Indacaterol 150 μg showed the greatest efficacy for SGRQ and Indacaterol 300 μg for FEV 1 and Transition Dyspnea Index. Conclusion Indacaterol is expected to be comparable to formoterol, salmeterol, and tiotropium, providing higher FEV 1 than formoterol and salmeterol and greater improvement in the SGRQ total score than tiotropium. Indacaterol 150 μg provided comparable improvement in dyspnea, while Indacaterol 300 μg demonstrated the greatest response overall.

  • long term safety and efficacy of Indacaterol a long acting β2 agonist in subjects with copd a randomized placebo controlled study
    Chest, 2011
    Co-Authors: Roger Owen, Kenneth R Chapman, Stephen I. Rennard, Cheryl Lassen, Angeli Dogra, Benjamin Kramer
    Abstract:

    Background Indacaterol is an inhaled, long-acting β 2 -agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind Indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of Indacaterol. Efficacy end points included trough (24 h postdose) FEV 1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving Indacaterol, 150 μg; Indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV 1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P P 4 units. Conclusions During 1 year of treatment, Indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. Trial registry ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov

  • long term safety and efficacy of Indacaterol a long acting β 2 agonist in subjects with copd
    Chest, 2011
    Co-Authors: Roger Owen, Kenneth R Chapman, Stephen I. Rennard, Cheryl Lassen, Angeli Dogra, Benjamin Kramer
    Abstract:

    Background Indacaterol is an inhaled, long-acting β 2 -agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind Indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of Indacaterol. Efficacy end points included trough (24 h postdose) FEV 1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]). Results Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving Indacaterol, 150 μg; Indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV 1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P P 4 units. Conclusions During 1 year of treatment, Indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. Trial registry ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov

  • Profiling the bronchodilator effects of the novel ultra-long-acting β2-agonist Indacaterol against established treatments in chronic obstructive pulmonary disease.
    Therapeutic Advances in Respiratory Disease, 2011
    Co-Authors: Claus Vogelmeier, Roger Owen, Craig Laforce, Helgo Magnussen, Benjamin Kramer
    Abstract:

    : Indacaterol is a novel, inhaled, ultra-long-acting β(2)-agonist providing 24-h bronchodilation with once-daily (od) dosing for maintenance use in patients with chronic obstructive pulmonary disease (COPD). This article reviews the bronchodilator properties of Indacaterol compared with other treatments used in COPD. Data from five published placebo-controlled studies were reviewed. Two 14-day crossover studies, the first comparing Indacaterol 300 µg od with salmeterol 50 µg twice daily (bid), the second comparing Indacaterol 150 µg and 300 µg od with tiotropium 18 µg od, assessed forced expiratory volume in 1 s (FEV(1)) at 24 h postdose (trough). Third, a 14-day crossover study evaluated trough FEV(1) following Indacaterol 300 µg dosed morning or evening compared with salmeterol 50 µg bid. Fourth, a single-dose study of Indacaterol 150 and 300 µg measured FEV(1) at 5 min postdose compared with salmeterol/fluticasone 50/500 µg and salbutamol 200 µg. Finally, data from a 1-year study with Indacaterol 300 µg and formoterol 12 µg bid were examined to determine whether bronchodilation was maintained long term. In the first two studies, Indacaterol increased trough FEV(1) after 14 days by a statistically significant and clinically relevant margin over placebo; Indacaterol had a greater effect than salmeterol and a similar effect to tiotropium. In the third study, Indacaterol had the same effect on trough FEV(1) whether dosed in the morning or evening. In the fourth study, the onset of the bronchodilator effect of Indacaterol was similar to that of salbutamol. In the fifth study, the bronchodilator effect of Indacaterol on trough FEV(1) was maintained at a significant and clinically relevant level over 52 weeks, whereas the bronchodilator effect of formoterol diminished over time. To conclude, Indacaterol is a highly effective bronchodilator that is superior to or at least as effective as other available long-acting bronchodilators for COPD.

Mark Higgins - One of the best experts on this subject based on the ideXlab platform.

  • Turning a Molecule into a Medicine: the Development of Indacaterol as a Novel Once-Daily Bronchodilator Treatment for Patients with COPD
    Drugs, 2014
    Co-Authors: Lorraine Murphy, Ronald Dahl, Mark Higgins, Stephen Rennard, James Donohue, Mathieu Molimard, Kai-michael Beeh, Juergen Dederichs, Hans-jürgen Fülle, David Young
    Abstract:

    Indacaterol is the first once-daily, long-acting β_2-adrenergic agonist (LABA) approved for the treatment of chronic obstructive pulmonary disease (COPD). Indacaterol was developed using a combination of informed drug design and molecular chemistry to generate a β_2-adrenergic agonist with a fast onset and long duration of action, enabling once-daily dosing with an acceptable safety profile. Early preclinical studies with Indacaterol demonstrated these characteristics, and this promising molecule was taken into clinical development, originally for asthma treatment. Subsequent safety concerns over LABA monotherapy in patients with asthma redirected Indacaterol’s development to centre on COPD, where a good evidence base and guideline recommendations for bronchodilator monotherapy existed. Clinical development was initially complicated by different inhaler devices and differing doses of Indacaterol. Using a phase III innovative adaptive-design clinical trial (INHANCE), Indacaterol 150 and 300 μg once-daily doses were selected to be taken forward into the phase III INERGIZE programme. This programme delivered placebo-controlled and active-comparator data, including comparisons with formoterol, tiotropium and salmeterol/fluticasone, as well as the use of Indacaterol in combination with tiotropium. Together, these studies provided a comprehensive assessment of the benefit–risk profile of Indacaterol, allowing for regulatory submission. Indacaterol was first approved at once-daily doses of 150 and 300 μg in the European Union in 2009, followed by 150 µg in Japan (2011) and China (2012), and 75 μg in the United States (2011). To date, Indacaterol is approved and marketed in more than 100 countries worldwide for once-daily maintenance treatment of COPD.

  • sustained 24 hour efficacy of once daily Indacaterol 300 μg in patients with chronic obstructive pulmonary disease a randomized crossover study
    Pulmonary Pharmacology & Therapeutics, 2011
    Co-Authors: Craig Laforce, Roger Owen, David Young, Mark Higgins, Joseph Aumann, Luis De Teresa Parreno, A Iqbal, Benjamin Kramer
    Abstract:

    Abstract Purpose Indacaterol is a novel, once daily, inhaled ultra-long-acting β2-agonist for the treatment of chronic obstructive pulmonary disease (COPD). Here we compared the 24-h spirometry profile of once daily Indacaterol 300 μg with that of placebo and twice daily salmeterol 50 μg in patients with COPD. Methods This randomized, multicenter, placebo-controlled, crossover study comprised three 14-day treatment periods (with 14-day washouts). Patients (male/female ≥40 years) with moderate-to-severe COPD were randomized to receive double-blind Indacaterol 300 μg or placebo once daily, or open-label salmeterol 50 μg twice daily. The primary outcome measure was 24-h post-dose (trough) FEV1 (mean of FEV1 at 23 h 10 min and 23 h 45 min post-Indacaterol dose) after 14 days. FEV1 was assessed at multiple time points on Days 1 and 14 of each treatment period. Safety and tolerability were also monitored. Results Of 68 randomized patients, 61 completed. Trough FEV1 (primary endpoint) on Day 14 for Indacaterol was 200 mL higher than placebo (p  Conclusions Once daily Indacaterol 300 μg produced effective sustained 24-h bronchodilation from the first dose, an efficacy profile superior to placebo and twice daily salmeterol. Given its effective bronchodilation with once daily dosing, Indacaterol is likely to be a useful treatment option for patients with moderate-to-severe COPD.

  • Indacaterol once daily is equally effective dosed in the evening or morning in copd
    Respiratory Medicine, 2010
    Co-Authors: Helgo Magnussen, Ralph Woessner, D Jack, Mark Higgins, C Verkindre, Dalal Jadayel, Michelle Henley, Benjamin Kramer
    Abstract:

    Summary Indacaterol is a novel, inhaled, long-acting β 2 -agonist providing 24-h bronchodilation with once-daily (o.d.) dosing in patients with COPD. In this double-blind, incomplete block crossover study, patients with moderate-to-severe COPD were randomised to receive three treatment cycles from: Indacaterol 300 μg o.d. dosed PM or AM, salmeterol 50 μg twice daily or placebo, each for 14 days. Trough FEV 1 was measured 24 h after Indacaterol, and 12 h after salmeterol. Ninety-six patients (mean age: 64 years; post-bronchodilator FEV 1 57% predicted, FEV 1 /FVC 55%) were randomised; 83 completed. After 14 days, the difference vs. placebo in trough FEV 1 for PM Indacaterol was 200 mL ( p p 1 for PM Indacaterol was 110 mL higher ( p p  = NS). Over 14 days, vs. placebo, both PM and AM Indacaterol improved the % of nights with no awakenings (by 11.9 and 8.1 points; p p p Indacaterol provided 24-h bronchodilation and improvement in symptoms regardless of whether taken regularly in the morning or evening. Clinical trial registration: ClinicalTrials.gov NCT00615030.

  • Indacaterol provides 24 hour bronchodilation in copd a placebo controlled blinded comparison with tiotropium
    Respiratory Research, 2010
    Co-Authors: C Vogelmeier, Roger Owen, D Jack, Mark Higgins, David Ramosbarbon, Simon Piggott, Benjamin Kramer
    Abstract:

    Background: Indacaterol is a novel, inhaled, once-daily, ultra-long-acting b2-agonist for the treatment of chronic obstructive pulmonary disease (COPD). This randomized, double-blind study compared the bronchodilator efficacy of Indacaterol with that of placebo and tiotropium in patients with moderate-to-severe COPD. Methods: In an incomplete-block, multi-dose, three-period, crossover design, patients received three of the following four treatments: Indacaterol 150 μg, Indacaterol 300 μg, tiotropium 18 μg and placebo, each once-daily for 14 days. Each treatment period was separated by a 14-day washout. Study drug was supplied daily by blinded, third party study personnel to maintain blinding of patients and investigators. The primary efficacy variable was trough forced expiratory volume in one second (FEV1) at 24 h post-dose after 14 days. The study was powered to demonstrate non-inferiority of Indacaterol to tiotropium for this variable. Results: A total of 169 patients were randomized (mean age 65 years); 153 (90.5%) completed. Trough FEV1 after 14 days with Indacaterol 150 μg and 300 μg was statistically and clinically superior to placebo, with differences (95% CI) of 170 (120-220) and 150 (100-200) mL respectively (both p < 0.001). For this endpoint, both doses of Indacaterol not only met the criterion for non-inferiority compared with tiotropium, but also achieved numerically higher values, with differences versus tiotropium of 40 and 30 mL for Indacaterol 150 and 300 μg, respectively. At 5 min post-dose on Day 1, the mean FEV1 for both Indacaterol doses was significantly higher than placebo (by 120 and 130 mL for Indacaterol 150 and 300 μg, respectively; p < 0.001) and tiotropium (by 80 mL for both doses; p < 0.001). Adverse events were reported by similar proportions of patients: 31.4%, 29.5%, 28.3% and 28.5% for Indacaterol 150 μg and 300 μg, tiotropium and placebo treatments, respectively. Conclusions: Once-daily Indacaterol provided clinically and statistically significant 24-h bronchodilation. Indacaterol was at least as effective as tiotropium, with a faster onset of action (within 5 min) on the first day of dosing. Indacaterol should prove useful in patients with moderate-to-severe COPD, for whom treatment with one or more classes of long-acting bronchodilator is recommended. Trial registration: ClinicalTrials.gov: NCT00615459, EudraCT number: 2007-004071-19

  • onset of action of Indacaterol in patients with copd comparison with salbutamol and salmeterol fluticasone
    International Journal of Chronic Obstructive Pulmonary Disease, 2010
    Co-Authors: Beatrix Balint, Roger Owen, Mark Higgins, Henrik Watz, Carolynn Amos, Benjamin Kramer
    Abstract:

    BACKGROUND: Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of chronic obstructive pulmonary disease (COPD). OBJECTIVES: this study compared the onset of action of single doses of Indacaterol 150 and 300 μg with salbutamol 200 μg, salmeterol-fluticasone 50/500 μg, and placebo in moderate-to-severe COPD patients. METHODS: this was a multicenter, randomized, double-blind, placebo-controlled crossover study. The primary variable was forced expiratory volume in one second (FEV(1)) at five minutes postdose. RESULTS: out of 89 patients randomized (mean age 62 years), 86 completed the study. At five minutes postdose, both Indacaterol doses were statistically and clinically superior to placebo (P < 0.001), with treatment-placebo differences in FEV(1) of 100 (95% confidence interval [CI] 70-130) mL and 120 (95% CI 90-150) mL for Indacaterol 150 and 300 μg, respectively. FEV(1) at five minutes postdose with both Indacaterol doses was numerically higher than for salbutamol (10 and 30 mL for Indacaterol 150 and 300 μg, respectively) and significantly higher than for salmeterol-fluticasone (50 mL, P = 0.003; 70 mL, P < 0.001, respectively). Moreover, both Indacaterol doses showed significantly higher FEV(1) than placebo (P < 0.001) at all postdose time points. The numbers of patients with an FEV(1) increase of at least 12% and 200 mL at five minutes postdose were 16 (18.8%), 24 (27.6%), 20 (23.3%), 8 (9.1%), and 3 (3.4%) for Indacaterol 150 and 300 μg, salbutamol 200 μg, salmeterol-fluticasone 50/500 μg, and placebo, respectively. CONCLUSIONS: single doses of Indacaterol 150 and 300 μg demonstrated a fast onset of action similar to that for salbutamol and faster than that for salmeterol-fluticasone.

Cheryl Lassen - One of the best experts on this subject based on the ideXlab platform.

  • Comparative Effectiveness Research/Health Technology Assessment Efficacy of Once-Daily Indacaterol Relative to Alternative Bronchodilators in COPD: A Patient-Level Mixed Treatment Comparison
    2020
    Co-Authors: Shannon Cope, Roger Owen, Gorana Capkun-niggli, Rupert Gale, Cheryl Lassen, Gert J.d. Bergman, Jeroen P. Jansen
    Abstract:

    Objective: Indacaterol was evaluated versus placebo, formoterol, and salmeterol in randomized controlled trials. No direct comparisons, however, are available for Indacaterol 150 g with formoterol or Indacaterol 300 g with salmeterol. Indacaterol trial evidence was synthesized to provide coherent estimates of Indacaterol 150 g and Indacaterol 300 g relative to formoterol, salmeterol, and tiotropium. Methods: Four randomized controlled trials were combined with Bayesian mixed treatment comparisons by using individual patientlevel data. End points of interest were trough forced expiratory volume in 1 second (FEV1), St. George’s Respiratory Questionnaire (SGRQ) total score and response (4 points), and Transition Dyspnea Index total score and response (1 point). Results: Indacaterol 150 g demonstrated a higher FEV1 than did formoterol at 12 weeks and 6 months (0.10 L difference; 95% credible interval [CrI] 0.06 – 0.14), as did Indacaterol 300 g versus salmeterol (0.06 L difference at 12 weeks; CrI 0.02– 0.10; 0.06 L at 6 months; CrI 0.02– 0.11). Regarding SGRQ, Indacaterol 150 g demonstrated a comparable proportion of responders versus formoterol, as did Indacaterol 300 g versus salmeterol. In comparison to tiotropium, Indacaterol 150 g demonstrated a greater proportion of responders (odds ratio 1.52 at 12 weeks; CrI 1.15–2.00). For Transition Dyspnea Index, Indacaterol 150 g and formoterol showed a similar response. Indacaterol 300 g was more efficacious than salmeterol (odds ratio 1.65 at 12 weeks; CrI 1.16 – 2.34). Overall, Indacaterol 150 g showed the greatest efficacy for SGRQ and Indacaterol 300 g for FEV1 and Transition Dyspnea Index. Conclusion: Indacaterol is expected to be comparable to formoterol, salmeterol, and tiotropium, providing higher FEV1 than formoterol and salmeterol and greater improvement in the SGRQ total score than tiotropium. Indacaterol 150 g provided comparable improvement in dyspnea, while Indacaterol 300 g demonstrated the greatest response

  • Efficacy of Once-Daily Indacaterol Relative to Alternative Bronchodilators in COPD: A Patient-Level Mixed Treatment Comparison
    Value in Health, 2012
    Co-Authors: Shannon Cope, Roger Owen, Gorana Capkun-niggli, Rupert Gale, Cheryl Lassen, Gert J.d. Bergman, Mario J.n.m. Ouwens, Jeroen P. Jansen
    Abstract:

    Abstract Objective Indacaterol was evaluated versus placebo, formoterol, and salmeterol in randomized controlled trials. No direct comparisons, however, are available for Indacaterol 150 μg with formoterol or Indacaterol 300 μg with salmeterol. Indacaterol trial evidence was synthesized to provide coherent estimates of Indacaterol 150 μg and Indacaterol 300 μg relative to formoterol, salmeterol, and tiotropium. Methods Four randomized controlled trials were combined with Bayesian mixed treatment comparisons by using individual patient-level data. End points of interest were trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and response (≥4 points), and Transition Dyspnea Index total score and response (≥1 point). Results Indacaterol 150 μg demonstrated a higher FEV 1 than did formoterol at 12 weeks and 6 months (0.10 L difference; 95% credible interval [CrI] = 0.06–0.14), as did Indacaterol 300 μg versus salmeterol (0.06 L difference at 12 weeks; CrI=0.02–0.10; 0.06 L at 6 months; CrI=0.02–0.11). Regarding SGRQ, Indacaterol 150 μg demonstrated a comparable proportion of responders versus formoterol, as did Indacaterol 300 μg versus salmeterol. In comparison to tiotropium, Indacaterol 150 μg demonstrated a greater proportion of responders (odds ratio=1.52 at 12 weeks; CrI 1.15–2.00). For Transition Dyspnea Index, Indacaterol 150 μg and formoterol showed a similar response. Indacaterol 300 μg was more efficacious than salmeterol (odds ratio=1.65 at 12 weeks; CrI 1.16–2.34). Overall, Indacaterol 150 μg showed the greatest efficacy for SGRQ and Indacaterol 300 μg for FEV 1 and Transition Dyspnea Index. Conclusion Indacaterol is expected to be comparable to formoterol, salmeterol, and tiotropium, providing higher FEV 1 than formoterol and salmeterol and greater improvement in the SGRQ total score than tiotropium. Indacaterol 150 μg provided comparable improvement in dyspnea, while Indacaterol 300 μg demonstrated the greatest response overall.

  • efficacy and tolerability of Indacaterol 75 μg once daily in patients aged 40 years with chronic obstructive pulmonary disease results from 2 double blind placebo controlled 12 week studies
    Clinical Therapeutics, 2011
    Co-Authors: Edward Kerwin, David Lawrence, Cheryl Lassen, Mark H Gotfried, Benjamin Kramer
    Abstract:

    Abstract Background Indacaterol is the first once-daily, long-acting, inhaled β 2 -agonist bronchodilator for maintenance treatment of chronic obstructive pulmonary disease (COPD). Two studies (previously reported in a Congress abstract) were performed in 2010 to provide efficacy and tolerability data to support the application for approval in the United States of Indacaterol 75 μg once daily, a dose lower than that previously investigated in most studies. Objective The primary objective was to evaluate the efficacy of Indacaterol 75 μg once daily in terms of 24-hour post-dose (“trough”) forced expiratory volume in the first second of respiration (FEV 1 ) compared with placebo after 12 weeks of treatment. Methods Patients with moderate to severe COPD were randomized to receive double-blind treatment with Indacaterol 75 μg once daily (n = 163 and 159) or placebo (n = 160 and 159) for 12 weeks. In addition to trough FEV 1 after 12 weeks, rescue albuterol use, health status (St. George's Respiratory Questionnaire [SGRQ]), and tolerability were evaluated. Clinically relevant differences between active and placebo treatments were defined as ≥120 mL for trough FEV 1 and a decrease of ≥4 units in SGRQ total score. Results Of patients enrolled in the 2 studies, 54% were men, and 90% and 94% were white, with mean age 64 and 61 years. Mean duration of COPD was 7 years; smoking history was 52 pack-years; and 45% and 37% of patients were receiving inhaled corticosteroid therapy. At week 12, Indacaterol demonstrated clinically relevant bronchodilator efficacy, increasing trough FEV 1 by ≥120 mL versus placebo ( P P P P ≤ 0.01). Adverse events were reported for 49% and 45% of patients receiving Indacaterol therapy, and for 46% and 41% receiving placebo. Conclusions Compared with placebo, Indacaterol 75 μg once daily provided statistically significant and clinically relevant 24-hour bronchodilation and was well tolerated. In patients receiving Indacaterol, the reduction in rescue albuterol use was statistically significant. Changes in health status also were statistically significant compared with placebo, although the differences of 3.6 and 3.8 units were below the predefined 4-unit level of clinical relevance. The results of these studies suggest that Indacaterol 75 μg once daily is an effective maintenance treatment in patients with moderate to severe COPD. ClinicalTrials.gov identifiers: NCT01072448 and NCT01068600 .

  • blinded 12 week comparison of once daily Indacaterol and tiotropium in copd
    European Respiratory Journal, 2011
    Co-Authors: Roland Buhl, Cheryl Lassen, Benjamin Kramer, Michelle Henley, L J Dunn, C Disdier, C Amos, Intensity Study Investigators
    Abstract:

    Two, once daily ( q.d. ) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β 2 -agonist Indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with Indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on “trough” (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 versus 1.43; p versus 39.2; p versus -3.0), and were significantly more likely to achieve clinically relevant improvements in these end-points (Indacaterol versus tiotropium odds ratios of 1.49 for TDI and 1.43 for SGRQ, both p Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, Indacaterol provided significantly greater improvements in clinical outcomes.

  • safety of Indacaterol in the treatment of patients with copd
    International Journal of Chronic Obstructive Pulmonary Disease, 2011
    Co-Authors: James F Donohue, Oliver Kornmann, David Lawrence, Cheryl Lassen, Dave Singh, Benjamin Kramer
    Abstract:

    PURPOSE: Pooled data were analyzed to evaluate the safety and tolerability of Indacaterol, a once-daily inhaled long-acting ?(2)-agonist for chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind Indacaterol 75 ?g (n = 449), 150 ?g (n = 2611), 300 ?g (n = 1157), or 600 ?g once daily (n = 547); formoterol 12 ?g twice daily (n = 556); salmeterol 50 ?g twice daily (n = 895); placebo (n = 2012); or tiotropium 18 ?g once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs. RESULTS: The commonest adverse events with Indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were < 1 for all Indacaterol doses. Notable values for vital signs and measures of systemic ?(2)-adrenoceptor activity were rare with Indacaterol. The number of deaths adjusted per patient-year was lower with Indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008). CONCLUSION: Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.

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  • the impact of treatment with Indacaterol in patients with copd a post hoc analysis according to gold 2011 categories a to d
    Pulmonary Pharmacology & Therapeutics, 2015
    Co-Authors: Huib A M Kerstjens, David Lawrence, Ronald Dahl, David Young, James F Donohue, Gaetan Deslee, Oliver Kornmann
    Abstract:

    Background: Indacaterol is an inhaled, once-daily, ultra-long-acting beta(2)-agonist for the treatment of chronic obstructive pulmonary disease (COPD). We report on the effectiveness of Indacaterol and other bronchodilators compared with placebo in patients across the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 categories A to D. Methods: A post-hoc, subgroup pooled analysis of 6-month efficacy data from three randomized, placebo-controlled, parallel-group studies involving 3862 patients was performed across GOLD 2011 categories A to D, according to baseline forced expiratory volume in 1 s (FEV1) % predicted, modified Medical Research Council (mMRC) dyspnea scale, and exacerbation history in the 12 months prior to entry. Efficacy of once-daily Indacaterol 150 and 300 mu g, open-label tiotropium 18 mu g, twice-daily salmeterol 50 mu g, and formoterol 12 mu g was compared with placebo. End points analysed were trough FEV1, transition dyspnea index (TDI), and St George's Respiratory Questionnaire (SGRQ) total score, all at Week 26, and mean rescue medication use over 26 weeks. Results: Indacaterol 150 and 300 mu g significantly improved FEV1, compared with placebo across all GOLD groups. Indacaterol 150 and 300 jig also significantly improved TDI, SGRQ total score, and mean rescue medication use compared with placebo across most GOLD subgroups. Conclusions: Treatment selection according to patient's symptoms as well as lung function is an important consideration in maintenance treatment of COPD. Indacaterol 150 and 300 mu g effectively improved lung function and symptoms in patients across all GOLD 2011 categories. (C) 2015 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

  • monotherapy with Indacaterol once daily reduces the rate of exacerbations in patients with moderate to severe copd post hoc pooled analysis of 6 months data from three large phase iii trials
    Respiratory Medicine, 2015
    Co-Authors: Jadwiga A Wedzicha, David Lawrence, Roland Buhl, David Young
    Abstract:

    Summary Background In patients with COPD, exacerbations are associated with poor quality of life and may shorten survival. Prevention of exacerbations is, therefore, a key objective in COPD management. Indacaterol, a once-daily ultra-long-acting β 2 -agonist, has been shown to reduce exacerbations in various studies. This pooled analysis evaluated the effect of Indacaterol on exacerbations versus placebo. Methods Six-month data were pooled from three randomized, double-blind, and placebo-controlled studies: Indacaterol 300 μg versus placebo (1 year); Indacaterol 150 μg and 300 μg versus placebo (6 months); and Indacaterol 150 μg versus placebo (6 months). All treatments were administered oncedaily. Data from other treatment groups were excluded. All three studies enrolled patients aged ≥40 years with moderate-to-severe COPD and smoking history ≥20 pack-years. Time to exacerbation and exacerbation rate were analyzed. Results Overall, the pooled data set included 2716 patients (Indacaterol 150 μg [ n  = 746], Indacaterol 300 μg [ n  = 819], placebo [ n  = 1151]). Both Indacaterol doses 150 and 300 μg significantly reduced the COPD exacerbation rates compared with placebo (Rate ratios, RR [95% Confidence Interval, CI]: 0.69 [0.55–0.87], 0.71 [95% CI: 0.57–0.88] respectively; both p  = 0.002). Over 6 months, Indacaterol 150 and 300 μg also significantly prolonged the time to first moderate-to-severe exacerbation versus placebo (Hazard ratios, HR [95% CI]: 0.74: [0.59–0.93], p  = 0.009; 0.73 [0.59–0.90], p  = 0.004, respectively). At months 3 and 6, clinically relevant improvements in lung function versus placebo were observed with Indacaterol 150 μg (Least squares mean treatment differences: Month 3 = 170 mL; Month 6 = 160 mL) and 300 μg (170 mL at both time-points; all p Conclusions In this pooled analysis, both Indacaterol doses, 150 and 300 μg, were associated with significant reductions in exacerbations and significant improvements in bronchodilation versus placebo. The results suggest once-daily Indacaterol is an effective treatment option for providing sustained bronchodilation and preventing exacerbations in patients with COPD.

  • once daily Indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease invigorate a randomised blinded parallel group study
    The Lancet Respiratory Medicine, 2013
    Co-Authors: Marc Decramer, Peter Frith, Kenneth R Chapman, Gilles Devouassoux, Carlos Cezar Fritscher, Ray Cameron, David Lawrence, Ronald Dahl, Muhammad Shoaib, David Young
    Abstract:

    Summary Background We compared the efficacy and safety of Indacaterol and tiotropium in patients with severe chronic obstructive pulmonary disease (COPD) and a history of at least one moderate to severe exacerbation in the previous 12 months. Methods In this multicentre, randomised, blinded, double-dummy, parallel group study, we enrolled patients aged 40 years or older with severe COPD and at least one exacerbation within the previous year. We used a computer-generated sequence to randomly allocate patients (1:1; stratified by baseline inhaled corticosteroid use, with the balance of treatments maintained at country level) to receive either Indacaterol (150 μg) or tiotropium (18 μg) once-daily for 52 weeks. Our primary and key secondary objectives were to investigate whether Indacaterol was non-inferior to tiotropium for trough forced expiratory volume in 1 s (FEV 1 ) at week 12 (primary endpoint), and for rate of exacerbations at week 52 (secondary endpoint). Analysis populations for the primary and key secondary endpoints were per-protocol sets. The safety set included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00845728. Findings Between March 16, 2009, and July 5, 2012, we enrolled and randomly allocated 3444 patients: 1723 to Indacaterol and 1721 to tiotropium. At week 12, the estimated least squares mean trough FEV 1 difference between the groups was −0·011 L (least squares mean with Indacaterol [n=1450] 1·134 L [SE 0·008] vs tiotropium [n=1467] 1·145 L [0·008]; one-sided 97·5% CI lower limit −0·026 L; p vs tiotropium 1065 [62%] of 1718 patients) or serious adverse events (Indacaterol, 263 [15%] of 1721 patients vs tiotropium, 255 [15%] of 1718 patients). Respiratory disorders, particularly worsening of COPD, were the most common adverse events (COPD: Indacaterol, 747 [43%] of 1721 patients and tiotropium, 665 [39%] of 1718 patients) and serious adverse events (COPD: Indacaterol, 147 [9%] of 1721 patients and tiotropium, 121 [7%] of 1718 patients). Interpretation Indacaterol and tiotropium provided clinically relevant improvements in lung function with comparable safety profiles. Tiotropium afforded greater protection from exacerbations, although the absolute number of events was small and the difference between treatments is of uncertain clinical importance. The present data offer evidence consistent with current guidelines. Funding Novartis Pharma AG.

  • Indacaterol therapy in patients with copd not receiving other maintenance treatment
    Respiratory Medicine, 2012
    Co-Authors: Marc Decramer, Antonio Rossi, David Lawrence, Danny Mcbryan
    Abstract:

    Summary Background Recent findings of rapid lung function decline in younger patients with moderate COPD severity suggest the need for effective early treatment. Aim To evaluate the effectiveness of Indacaterol as maintenance therapy in COPD patients not receiving other maintenance treatments. Methods Pooled data from three randomised, placebo-controlled studies provided a population of patients with moderate-to-severe COPD not receiving maintenance treatment at baseline and who received once-daily, double-blind treatment with Indacaterol 150 μg, Indacaterol 300 μg or placebo. Data from an open-label tiotropium treatment arm in one study were available for comparison. Efficacy evaluations included trough FEV 1 , dyspnoea (transition dyspnoea index, TDI) and health status (St George's Respiratory Questionnaire, SGRQ) at 6 months and risk of COPD exacerbations. Results The maintenance-naive population comprised 232 (Indacaterol 150 μg), 220 (Indacaterol 300 μg) and 325 (placebo) patients, plus 156 (tiotropium) (30% of overall study population). Patients treated with Indacaterol 150 and 300 μg had statistically significant improvements relative to placebo ( p 1 (170 and 180 mL), TDI total score (1.27 and 1.04 points), rescue use and SGRQ total score (−6.1 and −2.5 units) at 6 months. Patients receiving tiotropium had statistically significant improvements versus placebo ( p 1 (130 mL) and TDI total score (0.69 points). Exacerbations were rare and not significantly reduced by any treatment. Treatments were well tolerated. Conclusions Indacaterol, given to patients with moderate-to-severe COPD not receiving other maintenance treatments, provided effective bronchodilation with significant, clinically relevant improvements in dyspnoea and health status compared with placebo.

  • Assessing efficacy of Indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population.
    Respiratory Medicine, 2012
    Co-Authors: Yasuo To, Masaharu Kinoshita, Liang Wen Hang, Masakazu Ichinose, Naoko Okino, Niyati Prasad, Yoshinosuke Fukuchi, Tetsuji Kitawaki, David Lawrence
    Abstract:

    Summary Introduction This post hoc analysis evaluated the efficacy of Indacaterol, a novel inhaled once-daily long-acting β 2 -agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Methods Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to Indacaterol 150 μg, Indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV 1 (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Results Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) Indacaterol–placebo differences in trough FEV 1 at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior ( p p p Conclusions Indacaterol demonstrated clinically relevant improvements versus placebo in lung function, dyspnea and health status in Asian COPD patients irrespective of disease severity. Clinical Trials Identifier NCT00794157.

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