At a glance
ClinicalIndex Comparison Record- ✓Aged 40 to 80 years inclusive
- ✓Diagnosis of stable, moderate to severe COPD (GOLD stages II and III)
- ✓Current or former cigarette smoker with ≥10 pack-year history
- ✓Post-albuterol FEV1 ≥30% and <80% of predicted value
- ✕Hospitalization for acute COPD exacerbation within 3 months before screening
- ✕Respiratory tract infection or signs of COPD exacerbation in 6 weeks before screening
- ✕Any clinically significant respiratory conditions other than COPD
- ✕History or presence of asthma verified from medical records
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety Study of Two Fixed-Dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate, and Placebo All Administered Twice Daily (BID) to Patients With Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating Aclidinium 400 μg / Formoterol 12 μg, Aclidinium 400 μg / Formoterol 6 μg, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 128 participants across 20 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Study Details
Timeline
Interventions
Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods.
Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods.
Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods.
Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods.