Safety study of arformoterol tartrate inhalation solution in chronic obstructive pulmonary disease (COPD) subjects (clinicaltrials.gov) - Jun 26, 2012 - P3, N=841; Active, not recruiting ➔Completed
Trial completed • Asthma
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This study has been completed.
First Received on May 26, 2009. Last Updated on June 26, 2012
Sponsor:Sunovion
Information provided by (Responsible Party):Sunovion
ClinicalTrials.gov Identifier:NCT00909779
PurposeThis is a multi-center study to evaluate the long-term safety of arformoterol 15 mcg twice daily (BID) in the treatment of subjects with moderate-to-severe COPD. Study participation will consist of a total of 6 visits over approximately 1 year.
Condition
Chronic Obstructive Pulmonary Disease
Intervention
Drug: Arformoterol
Drug: Placebo
Phase
Phase 3
Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title:A Large Simple Safety Study of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Primary Outcome Measures:Time from randomization to respiratory death or first COPD exacerbation related hospitalization (whichever occurs first). [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
Enrollment:841
Study Start Date:June 2009
Study Completion Date:June 2012
Primary Completion Date:June 2012 (Final data collection date for primary outcome measure)
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