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Arformoterol

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James F Donohue – 1st expert on this subject based on the ideXlab platform

  • 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, 2018
    Co-Authors: James F Donohue, Michael D Stensland, Lauren Nelson, Vamsi Bollu, Donald E Stull, Valerie Williams, Nicola A Hanania

    Abstract:

    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

  • 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, 2018
    Co-Authors: James F Donohue, Michael D Stensland, Lauren Nelson, Vamsi Bollu, Donald E Stull, Valerie Williams, Nicola A Hanania

    Abstract:

    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.

  • health status of patients with moderate to severe copd after treatment with nebulized Arformoterol tartrate or placebo for 1 year
    Clinical Therapeutics, 2017
    Co-Authors: James F Donohue, Vaidyanathan Ganapathy, Michael D Stensland, Vamsi Bollu, Lauren Nelson

    Abstract:

    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.

Nicola A Hanania – 2nd expert on this subject based on the ideXlab platform

  • 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, 2018
    Co-Authors: James F Donohue, Michael D Stensland, Lauren Nelson, Vamsi Bollu, Donald E Stull, Valerie Williams, Nicola A Hanania

    Abstract:

    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.

  • 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, 2018
    Co-Authors: James F Donohue, Michael D Stensland, Lauren Nelson, Vamsi Bollu, Donald E Stull, Valerie Williams, Nicola A Hanania

    Abstract:

    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

  • one year safety and efficacy study of Arformoterol tartrate in patients with moderate to severe copd
    Chest, 2014
    Co-Authors: James F Donohue, Nicola A Hanania, Barry J Make, Matthew C Miles, Donald A Mahler, Lisa Curry, Robert Tosiello, Alistair Wheeler, Donald P Tashkin

    Abstract:

    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

John P Hanrahan – 3rd expert on this subject based on the ideXlab platform

  • a cumulative dose safety and tolerability study of Arformoterol in pediatric subjects with stable asthma
    Pediatric Pulmonology, 2011
    Co-Authors: J Hinkle, Kenneth Sciarappa, Elizabeth B Goodwin, J Hinson, E Kerwin, L Curry, John P Hanrahan

    Abstract:

    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.

  • the safety and efficacy of Arformoterol and formoterol in copd
    COPD: Journal of Chronic Obstructive Pulmonary Disease, 2011
    Co-Authors: Nicola A Hanania, James F Donohue, Rudolf A Baumgartner, Kenneth Sciarappa, Elizabeth B Goodwin, Harold Nelson, John P Hanrahan

    Abstract:

    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…

  • the influence of breathing pattern during nebulization on the delivery of Arformoterol using a breath simulator
    Respiratory Care, 2009
    Co-Authors: Andrea Bauer, Lisa Curry, Paul Mcglynn, Li Li Bovet, Pamela L Mims, John P Hanrahan

    Abstract:

    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]