Study identifier:D6570R00004
ClinicalTrials.gov identifier:NCT03181880
EudraCT identifier:N/A
CTIS identifier:N/A
To evaluate effectiveness of aclidinium bromide/formoterol fumarate dihydrate in chronic obstructive pulmonary disease
Chronic Obstructive Pulmonary Disease
Phase 4
No
Aclidinium bromide/formoterol fumarate combination, Standard of Care
All
0
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2017 by AstraZeneca
AstraZeneca
QUINTILESIMS INC
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Aclidinium/formoterol Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination | Drug: Aclidinium bromide/formoterol fumarate combination Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators. The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®). Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment. Other Name: Duaklir™ Genuair® |
Active Comparator: Bronchodilators The comparator arm consists of SOC. | Drug: Standard of Care Brochodilators Other Name: Standard of Care |