Comparison of aclidinium bromide and formoterol fumarate in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Study identifier:LAC-MD-24
ClinicalTrials.gov identifier:NCT00706914
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter, 4-Week Pilot Study to Assess Symptoms in Stable, Moderate to Severe COPD Patients Taking Aclidinium Bromide 200 mcg Once Daily in Combination With Formoterol Fumarate Once or Twice Daily Versus Formoterol Fumarate Twice Daily
Medical condition
Pulmonary Disease, Chronic Obstructive
Phase
Phase 2
Healthy volunteers
No
Study drug
Once-daily aclidinium/formoterol, Twice-daily formoterol fumarate, Placebo to formoterol fumarate, Once-daily formoterol fumarate
Sex
All
Actual Enrollment
156
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 30 Jun 2008
Primary Completion Date: 11 Nov 2008
Study Completion Date: 11 Nov 2008
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Once-daily aclidinium/formoterol Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening | Drug: Once-daily aclidinium/formoterol Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning Drug: Placebo to formoterol fumarate Inhaled placebo to formoterol fumarate once-daily in the evening |
| Experimental: Morning aclidinium/formoterol plus evening formoterol Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening | Drug: Once-daily aclidinium/formoterol Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning Drug: Once-daily formoterol fumarate Inhaled formoterol fumarate 12 μg once-daily in the evening |
| Active Comparator: Formoterol BID Formoterol fumarate 12 µg twice-daily (BID) | Drug: Twice-daily formoterol fumarate Inhaled formoterol fumarate 12 µg twice-daily (BID) |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
