A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

• Conditions: COPD
• Interventions: Drug: Arformoterol tartrate inhalation solution; Drug: Salmeterol MDI; Drug: Placebo

• Registration Number: NCT00685841
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

A 12 week study to investigate the safety and effectiveness of arformoterol given twice daily compared to placebo in subjects with COPD.

Detailed Description

This study is a double-blind, double-dummy, randomized, placebo- and active-controlled, multicenter, parallel-group study of adult subjects with a primary clinical diagnosis of COPD. Approximately 800 subjects were to be randomized in this study. Study participation consisted of a total of eight (8) study visits over approximately four (4) months for each subject. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 717

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Arformoterol tartrate inhalation solution	Arformoterol 50 mcg QD and placebo MDI
C	Arformoterol tartrate inhalation solution	Arformoterol 15 mcg BID and placebo MDI
D	Salmeterol MDI	Salmeterol MDI 42 mcg BID and placebo inhalation solution
E	Placebo	Placebo BID MDI and inhalation solution
B	Arformoterol tartrate inhalation solution	Arformoterol 25 mcg BID and placebo MDI

Primary Outcome Measures

Name	Time	Method
Percent change from study baseline FEV1 to the end of the dosing interval (12 hours post-second dose for the BID treatment arms and 24 hours post-dose for the QD treatment arm)	Weeks -2, 0, 3, 6, 9, 12

Secondary Outcome Measures

Name	Time	Method
Time-normalized area under the percent change from visit pre-dose curve for FEV1 over 12 hours (nAUC0-12)	Weeks -2, 0, 3, 6, 9, 12
Peak percent of predicted FEV1	Weeks -2, 0, 3, 6, 9, 12
Time-normalized area under the percent change from study baseline curve for FEV1 over 12 hours (nAUC0-12)	Weeks -2, 0, 3, 6, 9, 12
Time-normalized area under the percent change from study baseline curve for FEV1 over 24 hours (nAUC0-24)	Weeks -2, 0, 3, 6, 9, 12
Timepoint changes in FEV1	Weeks -2, 0, 3, 6, 9, 12
Time to onset of response	Weeks -2, 0, 3, 6, 9, 12
Time to peak change in FEV1	Weeks -2, 0, 3, 6, 9, 12
At-home and in-clinic peak expiratory flow rate (PEFR)	Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Ipratropium bromide MDI use	Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Racemic albuterol MDI use	Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Exacerbations of COPD	Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
COPD symptom ratings (over 12 weeks of treatment)	Weeks -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Relationship between plasma concentrations of (R,R) formoterol and selected pharmacodynamic parameters	Weeks -2, 0, 3, 6, 9, 12