The Experts below are selected from a list of 225 Experts worldwide ranked by ideXlab platform
James F Donohue - One of the best experts on this subject based on the ideXlab platform.
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Long-term health-related quality-of-life and symptom response profiles with Arformoterol in COPD: results from a 52-week trial.
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P
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long term health related quality of life and symptom response profiles with Arformoterol in copd results from a 52 week trial
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P<0.001; 95% confidence interval: 17.6-23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV1]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV1 (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo. Conclusion: In this study, Arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, Arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.
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health status of patients with moderate to severe copd after treatment with nebulized Arformoterol tartrate or placebo for 1 year
Clinical Therapeutics, 2017Co-Authors: James F Donohue, Vaidyanathan Ganapathy, Michael D Stensland, Vamsi Bollu, Lauren NelsonAbstract:Abstract Purpose Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding Arformoterol tartrate or placebo to patients' treatment regimens. Methods In this multicenter, double-blind trial, patients were randomized to receive nebulized Arformoterol 15 µg BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting β 2 -agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV 1 ) ≤65% of predicted, FEV 1 >0.50 L, age ≥40 years, smoking history ≥15 pack-years, and a baseline breathlessness severity grade ≥2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures. Findings At baseline, patients' mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the Arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either Arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received Arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (−0.18 vs 0.02; P = 0.001), symptoms (−0.21 vs 0.01; P = 0.002), functional state (−0.15 vs 0.02; P = 0.018), and mental state (−0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the Arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ ( P = 0.026). These improvements were only modestly correlated with improvements in FEV 1 ( r = −0.15; P Implications In this 52-week trial, Arformoterol-treated patients had greater improvements in health status than patients receiving placebo. Assessing health status along with lung function seems to provide additional information regarding the effectiveness of COPD maintenance treatments. ClinicalTrials.gov identifier: NCT00909779.
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review of drug safety and efficacy of Arformoterol in chronic obstructive pulmonary disease
Expert Opinion on Drug Safety, 2015Co-Authors: James F Donohue, Jill A OharAbstract:Introduction: The global initiative for chronic obstructive lung disease guidelines recommend maintenance therapy using long-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD) who have daily symptoms. Arformoterol is the (R, R) - enantiomer of the racemic formoterol and is more potent than (R, R/ S, S) - formoterol.Areas covered: Currently, Arformoterol is one of two nebulized long-acting β-agonists on the market. It has a low incidence of cardiovascular side effects with incidence of arrhythmia and ischemia similar to placebo. β-adrenergic adverse effects are infrequent, numerically lower than formoterol, but have a quicker onset of action than salmeterol. There was no observed clinical tolerance over 12 months. Arformoterol is safe in combination therapy with inhaled corticosteroids, tiotropium and rescue inhalers. A 12-month Phase IV trial found no increased risk of respiratory death or COPD exacerbation-related hospitalizations. Arformoterol can potentially benefit p...
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one year safety and efficacy study of Arformoterol tartrate in patients with moderate to severe copd
Chest, 2014Co-Authors: James F Donohue, Nicola A Hanania, Barry J Make, Matthew C Miles, Donald A Mahler, Lisa Curry, Robert Tosiello, Alistair Wheeler, Donald P TashkinAbstract:Abstract BACKGROUND: Arformoterol tartrate (Arformoterol, 15 μg bid) is a nebulized long-acting β 2 -agonist approved for maintenance treatment of COPD. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV 1 ≤ 65% predicted, FEV 1 > 0.50 L, FEV 1 /FVC ≤ 70%, and ≥ 15 pack-year smoking history) received Arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization. RESULTS: Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for Arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for Arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving Arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving Arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with Arformoterol than placebo ( P = .003). Numerically more patients on Arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV 1 and FVC were greater with Arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with Arformoterol vs placebo ( P CONCLUSIONS: Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00909779; URL:www.clinicaltrials.gov
Nicola A Hanania - One of the best experts on this subject based on the ideXlab platform.
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long term health related quality of life and symptom response profiles with Arformoterol in copd results from a 52 week trial
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P<0.001; 95% confidence interval: 17.6-23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV1]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV1 (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo. Conclusion: In this study, Arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, Arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.
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Long-term health-related quality-of-life and symptom response profiles with Arformoterol in COPD: results from a 52-week trial.
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P
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one year safety and efficacy study of Arformoterol tartrate in patients with moderate to severe copd
Chest, 2014Co-Authors: James F Donohue, Nicola A Hanania, Barry J Make, Matthew C Miles, Donald A Mahler, Lisa Curry, Robert Tosiello, Alistair Wheeler, Donald P TashkinAbstract:Abstract BACKGROUND: Arformoterol tartrate (Arformoterol, 15 μg bid) is a nebulized long-acting β 2 -agonist approved for maintenance treatment of COPD. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV 1 ≤ 65% predicted, FEV 1 > 0.50 L, FEV 1 /FVC ≤ 70%, and ≥ 15 pack-year smoking history) received Arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization. RESULTS: Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for Arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for Arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving Arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving Arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with Arformoterol than placebo ( P = .003). Numerically more patients on Arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV 1 and FVC were greater with Arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with Arformoterol vs placebo ( P CONCLUSIONS: Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00909779; URL:www.clinicaltrials.gov
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the safety and efficacy of Arformoterol and formoterol in copd
COPD: Journal of Chronic Obstructive Pulmonary Disease, 2011Co-Authors: Nicola A Hanania, James F Donohue, Kenneth Sciarappa, Rudolf A Baumgartner, Elizabeth B Goodwin, Harold Nelson, John P HanrahanAbstract:ABSTRACTThis study evaluated the safety and efficacy of Arformoterol and formoterol over 6-months in subjects with COPD. In a multi-center, 6-month randomized, double-blind, double-dummy trial, subjects with COPD (mean FEV1 1.21 L, ∼41.0%% predicted) were randomized to receive either nebulized Arformoterol (15μg BID [[n == 149]][[ARF 15]], 25μg BID [[n == 147]][[ARF 25]]), or racemic formoterol (12μg BID [[n == 147]][[FORM]]) delivered by DPI. The proportion of subjects with any post-treatment adverse event for ARF 15, ARF 25 μg, and FORM was 67.8%%, 76.2%% and 66.7%%, respectively, and those with at least one COPD exacerbation was 32.2%%, 30.6%%, and 22.4%%, respectively. Pulmonary function improved for all treatment groups and was maintained throughout the study. Mean change from baseline at 6-months for ARF 15, ARF 25 and FORM in peak FEV1 was 0.30L, and 0.34L, and 0.26L, respectively, in 24-hour trough FEV1 was, 0.10L, 0.14L, and 0.09L, and in inspiratory capacity was, 0.20L, 0.37L, and 0.23L. Dyspnea...
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Arformoterol tartrate in the treatment of copd
Expert Review of Respiratory Medicine, 2010Co-Authors: Mario Cazzola, Nicola A Hanania, Maria Gabriella MateraAbstract:Some basic scientific data suggest that ( S)-enantiomers of b 2 -agonists have different and sometimes opposing effects to (R)-enantiomers. These data may explain the paradoxical response of the airways to the repeated, chronic administration of racemic b 2 -agonists. Therefore, it is possible that the use of (R)-enantiomers of b 2 -agonists may be an alternative option to reduce the risks of long-term administration of inhaled long-acting agents. Arformoterol is the (R,R)-enantiomer of formoterol. It is currently available for use as a nebulized solution of Arformoterol tartrate and is approved in the USA for twice-daily administration in patients with chronic obstructive pulmonary disease (COPD). Clinical trials in COPD patients have demonstrated that Arformoterol is as effective in improving lung function and symptoms as other available long-acting inhaled b 2 -agonists. Moreover, its safety for long-term administration has been documented in this population. These findings indicate that Arformoterol is an effective option for patients with COPD who could benefit from sustained bronchodilation delivered through nebulization, and can be an alternative for patients who cannot use conventional inhaler devices, including metered-dose inhalers or dry-powder devices.
John P Hanrahan - One of the best experts on this subject based on the ideXlab platform.
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a cumulative dose safety and tolerability study of Arformoterol in pediatric subjects with stable asthma
Pediatric Pulmonology, 2011Co-Authors: J Hinkle, Kenneth Sciarappa, Elizabeth B Goodwin, J Hinson, E Kerwin, L Curry, John P HanrahanAbstract:Purpose Short-acting β2-agonists (SABAs) are recommended for treating acute pediatric asthma. The long-acting β2-agonist (LABA) Arformoterol is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol acts rapidly, is delivered via nebulization, and, as such, raises concerns from the FDA over possible off-label use in acute asthma in children. As a step to investigate this issue, this study evaluated the safety and tolerability of three consecutive doses of Arformoterol administered over 1 hr in children with stable asthma. Methods This study consisted of a double-blind, crossover period in which subjects (ages 2–11 years) with stable asthma were randomized to three consecutive nebulized doses of Arformoterol (7.5 µg/dose) or levalbuterol (0.63 mg/dose) administered over 1-hr (0, 30, and 60 min) followed by an open-label period with three consecutive doses of Arformoterol (15 µg/dose) administered over 1 hr. Endpoints were change in heart rate, blood pressure, and serum potassium and glucose levels. Other endpoints included adverse events and pulmonary function. Results There were no clinically important mean changes from pre-dose in heart rate, blood pressure, or serum glucose levels, across treatment groups. Substantial declines in serum potassium levels were observed both 2 and 6 hr post-dosing. Two subjects had declines to 2.8 mEq/L and 2.9 mEq/L 2-hr post-dosing. Adverse events were infrequent and differences in forced expiratory volume in 1 sec and peak expiratory flow across treatment groups were not clinically meaningful. Conclusion In this study, in children with stable asthma, three consecutive doses of Arformoterol (7.5 and 15 µg) and levalbuterol were overall well tolerated. Nonetheless, serum potassium levels demonstrated substantial mean declines after dosing. These findings do not address or support the safety and tolerability of Arformoterol use in acute exacerbations of asthma in children. Pediatr. Pulmonol. 2011; 46:761–769. © 2011 Wiley-Liss, Inc.
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the safety and efficacy of Arformoterol and formoterol in copd
COPD: Journal of Chronic Obstructive Pulmonary Disease, 2011Co-Authors: Nicola A Hanania, James F Donohue, Kenneth Sciarappa, Rudolf A Baumgartner, Elizabeth B Goodwin, Harold Nelson, John P HanrahanAbstract:ABSTRACTThis study evaluated the safety and efficacy of Arformoterol and formoterol over 6-months in subjects with COPD. In a multi-center, 6-month randomized, double-blind, double-dummy trial, subjects with COPD (mean FEV1 1.21 L, ∼41.0%% predicted) were randomized to receive either nebulized Arformoterol (15μg BID [[n == 149]][[ARF 15]], 25μg BID [[n == 147]][[ARF 25]]), or racemic formoterol (12μg BID [[n == 147]][[FORM]]) delivered by DPI. The proportion of subjects with any post-treatment adverse event for ARF 15, ARF 25 μg, and FORM was 67.8%%, 76.2%% and 66.7%%, respectively, and those with at least one COPD exacerbation was 32.2%%, 30.6%%, and 22.4%%, respectively. Pulmonary function improved for all treatment groups and was maintained throughout the study. Mean change from baseline at 6-months for ARF 15, ARF 25 and FORM in peak FEV1 was 0.30L, and 0.34L, and 0.26L, respectively, in 24-hour trough FEV1 was, 0.10L, 0.14L, and 0.09L, and in inspiratory capacity was, 0.20L, 0.37L, and 0.23L. Dyspnea...
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the influence of breathing pattern during nebulization on the delivery of Arformoterol using a breath simulator
Respiratory Care, 2009Co-Authors: Andrea Bauer, Lisa Curry, Paul Mcglynn, Li Li Bovet, Pamela L Mims, John P HanrahanAbstract:BACKGROUND: Patients with obstructive airway conditions, including chronic obstructive pulmonary disease (COPD), use nebulizers for drug delivery. Tidal breathing patterns employed by patients during nebulized drug delivery may vary. It is unclear whether different breathing patterns affect the emitted quantity of nebulized drug. This in vitro study evaluated whether different tidal breathing patterns that encompass a range that could be observed in COPD patients influence the emitted amount of nebulized Arformoterol. METHODS: Breath-simulation experiments used a Pari LC Plus nebulizer in combination with the Duraneb 3000 portable aerosol system. Four breathing patterns that could represent a range of tidal volumes and inspiratory and expiratory times observed in patients with COPD were studied. The amount of Arformoterol on the inspiratory and expiratory filters, and the residual amount in the nebulizer bowl were determined via highpressure liquid chromatography. Results are expressed as a percent of the nominal dose (15 gi n 2 mL). RESULTS: The total amount of Arformoterol on the inspiratory filter increased with a longer inspiratory phase of tidal breathing (ranging from 8.0% to 13.1%), while the expiratory filter dose remained similar (7.9% to 8.7%). The total emitted dose (expiratory and inspiratory amounts combined) for all patterns was 16.0% to 21.1% of the nominal dose. Retained Arformoterol amount (not emitted) ranged from 55.9% to 62.3% of the nominal dose. CONCLUSIONS: These breath-simulation experiments suggest that only about 20% of the nominal 15-g Arformoterol dose was emitted from the nebulizer apparatus with each of the 4 tidal breathing patterns studied, and that a longer inspiratory phase was associated with greater inhaled dose. Key words: Arformoterol, nebulizer,aerosol,breath-simulation,emitteddose. [RespirCare2009;54(11):1488–1492.© 2009Daedalus Enterprises]
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compositions d Arformoterol et de tiotropium et leurs procedes d utilisation
2009Co-Authors: Holly Huang, John P Hanrahan, Elizabeth B Goodwin, Kendyl Schaefer, William T Andrews, Paul McglynnAbstract:L'invention porte sur des compositions et des procedes pour la prevention et/ou le traitement de troubles des voies respiratoires et/ou de troubles respiratoires. Les compositions comprennent de l'Arformoterol (l'isomere (R,R)-formoterol) et du tiotropium.
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output and aerosol properties of 5 nebulizer compressor systems with Arformoterol inhalation solution
Respiratory Care, 2009Co-Authors: Andrea Bauer, Lisa Curry, Paul Mcglynn, Li Li Bovet, Pamela L Mims, John P HanrahanAbstract:BACKGROUND: Arformoterol, the (R,R) isomer of formoterol, is approved as an inhalation solution for the treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. Multiple nebulizer systems are commercially available. Different nebulizers can differ significantly in drug output, which may impact drug delivery and clinical efficacy. This study compared the aerosol properties of Arformoterol delivered via 5 commonly used nebulizer systems for the home-care market. METHODS: The delivered dose of Arformoterol inhalation solution (15 g/2 mL) was collected in a glass Dreschel-type apparatus. The delivered amount in fine-droplet fraction was assessed with an Andersen cascade impactor, and droplet size (average median diameter and average percent < 5 m) was evaluated via laser diffraction. Compressor flow rate measurements were taken after 1 min and 6 min by placing the flow meter in line with each system. RESULTS: The Pari LC Plus, Updraft II Opti-Neb, and NebuTech systems delivered similar amounts of the 15-g nominal dose (from 23% to 25%). The Pari LC Star and Sidestream systems delivered slightly higher doses (31% and 35%, respectively). The nebulizer/compressor systems differed somewhat with respect to droplet size. The NebuTech delivered the lowest fine-droplet fraction (61%) via Andersen cascade impactor, and the smallest percent of droplets < 5 m (40%) via laser diffraction. The Pari LC Star and Sidestream delivered the highest fine-droplet fraction (100% and 93%, respectively), and the greatest percent of droplets < 5 m (84% and 88%). The fine-droplet fractions for the Updraft II Opti-Neb and Pari LC Plus were 93% and 89%, respectively, and the percent of droplets < 5 m was about 67%. Compressor flow rates ranged from 3.2 L/min (Pari LC Plus) to 5.4 L/min (NebuTech). CONCLUSIONS: The results of this study demonstrate that the choice of nebulizer/compressor system can influence the aerosol properties of Arformoterol inhalation solution and should be considered when prescribing nebulized medications.
Vamsi Bollu - One of the best experts on this subject based on the ideXlab platform.
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Long-term health-related quality-of-life and symptom response profiles with Arformoterol in COPD: results from a 52-week trial.
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P
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long term health related quality of life and symptom response profiles with Arformoterol in copd results from a 52 week trial
International Journal of Chronic Obstructive Pulmonary Disease, 2018Co-Authors: James F Donohue, Michael D Stensland, Vamsi Bollu, Lauren Nelson, Donald E Stull, Valerie Williams, Nicola A HananiaAbstract:Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of Arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized Arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with Arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for Arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P<0.001; 95% confidence interval: 17.6-23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV1]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV1 (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo. Conclusion: In this study, Arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, Arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.
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health status of patients with moderate to severe copd after treatment with nebulized Arformoterol tartrate or placebo for 1 year
Clinical Therapeutics, 2017Co-Authors: James F Donohue, Vaidyanathan Ganapathy, Michael D Stensland, Vamsi Bollu, Lauren NelsonAbstract:Abstract Purpose Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding Arformoterol tartrate or placebo to patients' treatment regimens. Methods In this multicenter, double-blind trial, patients were randomized to receive nebulized Arformoterol 15 µg BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting β 2 -agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV 1 ) ≤65% of predicted, FEV 1 >0.50 L, age ≥40 years, smoking history ≥15 pack-years, and a baseline breathlessness severity grade ≥2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures. Findings At baseline, patients' mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the Arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either Arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received Arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (−0.18 vs 0.02; P = 0.001), symptoms (−0.21 vs 0.01; P = 0.002), functional state (−0.15 vs 0.02; P = 0.018), and mental state (−0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the Arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ ( P = 0.026). These improvements were only modestly correlated with improvements in FEV 1 ( r = −0.15; P Implications In this 52-week trial, Arformoterol-treated patients had greater improvements in health status than patients receiving placebo. Assessing health status along with lung function seems to provide additional information regarding the effectiveness of COPD maintenance treatments. ClinicalTrials.gov identifier: NCT00909779.
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Exacerbations, health services utilization, and costs in commercially-insured COPD patients treated with nebulized long-acting β2-agonists.
Journal of Medical Economics, 2015Co-Authors: Yaozhu J. Chen, Vamsi Bollu, Maryam Navaie, Charles Makin, Bartolome R CelliAbstract:AbstractObjective:This retrospective cohort study compared exacerbations, health services utilization, and costs among chronic obstructive pulmonary disease (COPD) patients who received nebulized Arformoterol or nebulized formoterol therapy.Methods:Using PharMetrics Plus health plan claims, 417 nebulized long-acting β2-agonist (LABA) users meeting the study inclusion criteria were identified: had ≥2 fills of nebulized Arformoterol or nebulized formoterol from January 1, 2009, to December 31, 2011, adhered to using their index drug ≥60% of the days during 1 year post-index, were ≥35 years old and continuously enrolled 180 days pre- and 1 year post-index, and did not use a nebulized LABA or have an asthma diagnosis during the pre-index period. Descriptive and multivariate analyses were performed.Results:A total of 274 nebulized Arformoterol users and 143 nebulized formoterol users were identified with comparable demographic characteristics. However, significant differences were observed between the two grou...
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hospital readmissions following initiation of nebulized Arformoterol tartrate or nebulized short acting beta agonists among inpatients treated for copd
International Journal of Chronic Obstructive Pulmonary Disease, 2013Co-Authors: Vamsi Bollu, Frank R Ernst, J Karafilidis, Krithika Rajagopalan, Scott B Robinson, Sidney S BramanAbstract:Background Inpatient admissions for chronic obstructive pulmonary disease (COPD) represent a significant economic burden, accounting for over half of direct medical costs. Reducing 30-day readmissions could save health care resources while improving patient care. Recently, the Patient Protection and Affordable Care Act authorized reduced Medicare payments to hospitals with excess readmissions for acute myocardial infarction, heart failure, and pneumonia. Starting in October 2014, hospitals will also be penalized for excess COPD readmissions. This retrospective database study investigated whether use of Arformoterol, a nebulized long-acting beta agonist, during an inpatient admission, had different 30-day all-cause readmission rates compared with treatment using nebulized short-acting beta agonists (SABAs, albuterol, or levalbuterol).
Mario Cazzola - One of the best experts on this subject based on the ideXlab platform.
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Ultra-long-acting β: An Emerging Therapeutic Option for Asthma and Copd?-adrenoceptor Agonists: An Emerging Therapeutic Option for Asthma and Copd?
Drugs, 2020Co-Authors: Maria Gabriella Matera, Mario CazzolaAbstract:There has been a real interest recently in developing once-daily β2-adrenoceptor agonists (ultra-long-acting β2-adrenoceptor agonists [ultra-LABAs]) for treating asthma and chronic obstructive pulmonary disease (COPD) in an attempt to simplify their management, although an increasing amount of convincing data show an association of LABAs with a rise in asthma-related deaths and life-threatening experiences. This paper reviews the effects of different ultra-LABAs that are at varying stages of development. Arformoterol, carmoterol, indacaterol and GSK-159797 are ultra-LABAs that are likely to be introduced into the market before 2010. It is plausible that once-daily dose administration of an LABA will lead to increased convenience for patients, which may also lead to enhancement of adherence, and may have advantages leading to improved overall clinical outcomes in patients with asthma and COPD.
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Ultra-Long-Acting β2
Drugs, 2012Co-Authors: Maria Gabriella Matera, Mario CazzolaAbstract:There has been a real interest recently in developing once-daily β2-adrenoceptor agonists (ultra-long-acting β2-adrenoceptor agonists [ultra-LABAs]) for treating asthma and chronic obstructive pulmonary disease (COPD) in an attempt to simplify their management, although an increasing amount of convincing data show an association of LABAs with a rise in asthma-related deaths and life-threatening experiences. This paper reviews the effects of different ultra-LABAs that are at varying stages of development. Arformoterol, carmoterol, indacaterol and GSK-159797 are ultra-LABAs that are likely to be introduced into the market before 2010. It is plausible that once-daily dose administration of an LABA will lead to increased convenience for patients, which may also lead to enhancement of adherence, and may have advantages leading to improved overall clinical outcomes in patients with asthma and COPD.
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Arformoterol tartrate in the treatment of copd
Expert Review of Respiratory Medicine, 2010Co-Authors: Mario Cazzola, Nicola A Hanania, Maria Gabriella MateraAbstract:Some basic scientific data suggest that ( S)-enantiomers of b 2 -agonists have different and sometimes opposing effects to (R)-enantiomers. These data may explain the paradoxical response of the airways to the repeated, chronic administration of racemic b 2 -agonists. Therefore, it is possible that the use of (R)-enantiomers of b 2 -agonists may be an alternative option to reduce the risks of long-term administration of inhaled long-acting agents. Arformoterol is the (R,R)-enantiomer of formoterol. It is currently available for use as a nebulized solution of Arformoterol tartrate and is approved in the USA for twice-daily administration in patients with chronic obstructive pulmonary disease (COPD). Clinical trials in COPD patients have demonstrated that Arformoterol is as effective in improving lung function and symptoms as other available long-acting inhaled b 2 -agonists. Moreover, its safety for long-term administration has been documented in this population. These findings indicate that Arformoterol is an effective option for patients with COPD who could benefit from sustained bronchodilation delivered through nebulization, and can be an alternative for patients who cannot use conventional inhaler devices, including metered-dose inhalers or dry-powder devices.
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Ultra-Long-Acting β_2-Adrenoceptor Agonists
Drugs, 2007Co-Authors: Maria Gabriella Matera, Mario CazzolaAbstract:There has been a real interest recently in developing once-daily β2-adrenoceptor agonists (ultra-long-acting β_2-adrenoceptor agonists [ultra-LABAs]) for treating asthma and chronic obstructive pulmonary disease (COPD) in an attempt to simplify their management, although an increasing amount of convincing data show an association of LABAs with a rise in asthma-related deaths and life-threatening experiences. This paper reviews the effects of different ultra-LABAs that are at varying stages of development. Arformoterol, carmoterol, indacaterol and GSK-159797 are ultra-LABAs that are likely to be introduced into the market before 2010. It is plausible that once-daily dose administration of an LABA will lead to increased convenience for patients, which may also lead to enhancement of adherence, and may have advantages leading to improved overall clinical outcomes in patients with asthma and COPD.
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Ultra long-acting beta 2-agonists in development for asthma and chronic obstructive pulmonary disease.
Expert Opinion on Investigational Drugs, 2005Co-Authors: Mario Cazzola, Maria Gabriella Matera, Jan LötvallAbstract:After the discovery of formoterol and salmeterol, new candidates for long-acting β2-adrenoceptor agonists (LABAs) have emerged from various companies. In particular, once-daily β2-adrenoceptor agonists such as Arformoterol, carmoterol, indacaterol, GSK-159797, GSK-597901, 159802, 642444 and 678007 are under development for the treatment of asthma and chronic obstructive pulmonary disease. The majority of these compounds are (R,R)-isomers in order to control desensitisation and accumulation. Several options for combination products are currently being evaluated in parallel with the development of these ultra LABAs. Once-daily dosing of an ultra LABA would be a significant convenience and probably a compliance-enhancing advantage leading to improved overall clinical outcomes in patients with asthma and chronic obstructive pulmonary disease. The only limits set for the development of a LABA with a new product profile are medical needs and marketing opportunities.
