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Obstructive Lung Diseases |

A Large Simple Safety Study of Nebulized Arformoterol Tartrate: Incidence and Risk of Protocol-Defined COPD Exacerbations

Nicola Hanania, MD; James Donohue, MD; Barry Make, MD
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Baylor College of Medicine, Houston, TX


Chest. 2013;144(4_MeetingAbstracts):735A. doi:10.1378/chest.1704476
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Abstract

SESSION TITLE: COPD Treatment Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: This study was performed to evaluate the risk of life-threatening respiratory events (COPD exacerbation-related hospitalizations and respiratory death) during 1 year of treatment with arformoterol tartrate 15µg twice daily (ARF) compared with placebo in subjects with moderate-to-severe COPD.

METHODS: This was a double blind, randomized, placebo controlled, parallel group study. Subjects meeting inclusion criteria (≥40 years old with COPD, baseline FEV1 ≤50% of predicted, ≥15 pack year smoking history) were randomized to ARF (BROVANA® [arformoterol tartrate] Inhalation Solution, N=420) or placebo (N=421) for 1 year. Subjects remained on all other COPD medications except LABAs. Short acting bronchodilators were only withheld prior to visits and inhaled steroids and xanthines were permitted throughout at constant dosage. The primary assessment was time from randomization to a primary event (respiratory death or first COPD exacerbation related hospitalization, whichever occurred first). The rate of and risk for a protocol-defined COPD exacerbation (defined as an increase in respiratory symptoms that necessitated any change in baseline medication other than bronchodilators [anti-inflammatory agents, antibiotics, supplemental oxygen therapy] or required additional medical attention) was evaluated as a secondary assessment. Hazard ratio, 95%CI for hazard ratio and Wald test p-value for time to first protocol-defined COPD exacerbation were from a Cox proportional hazards regression model and were from a proportional means model for recurrent protocol defined COPD exacerbations.

RESULTS: 122 (29%) subjects in ARF group and 132 (31.4%) subjects in placebo group had 213 and 236 protocol-defined COPD exacerbations respectively. 71(16.9%) ARF-treated subjects versus 72(17.1%) placebo group subjects had 1 event; 29 (6.9%) ARF-treated subjects versus 34 (8.1%) placebo group subjects had 2 events; and 22 (5.2%) ARF-treated subjects versus 26 (6.2%) placebo group subjects had 3 or more events. The hazard ratio for first protocol-defined COPD exacerbation was 0.801 (p=0.078) and hazard ratio for recurrent protocol-defined COPD exacerbations was 0.768 (p=0.043).

CONCLUSIONS: In this long-term safety study, nebulized arformoterol tartrate 15µg BID for 1 year decreased the incidence and risk of protocol-defined COPD exacerbations.

CLINICAL IMPLICATIONS: The results of this study indicates that 1 year of treatment with arformoterol tartrate 15µg BID in patients with COPD reduced the risk and incidence of COPD exacerbations.

DISCLOSURE: Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals Inc, Grant monies (from industry related sources): Sunovion Pharmaceuticals Inc (past completed) James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals Inc Barry Make: Grant monies (from sources other than industry): National Heart, Lung, and Blood Institute, Grant monies (from industry related sources): Boehringer-Ingelheim, Forest, NABI, Pfizer, Consultant fee, speaker bureau, advisory committee, etc.: Abbott, AstraZeneca, Boehringer-Ingelheim, Breathe, Coviden, Ikaria, Sunovion, Forest, GSK, Merck, MedImmune, Novartis

No Product/Research Disclosure Information


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