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
ASTUTE is a pragmatic open randomised 12-week multinational trial to evaluate the effectiveness of aclidinium bromide/formoterol fumarate dihydrate fixed-dose combination compared to standard of care bronchodilators in chronic obstructive pulmonary disease.
ASTUTE is a longitudinal, randomised, multicentre, and multinational pragmatic study of patients with Chronic Obstructive Pulmonary Disease to evaluate the comparative effectiveness of Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®) and Standard of Care bronchodilators in patients treated with long acting bronchodilator monotherapies OR patients who abide to the following treatment category: patient is newly diagnosed, or naïve to maintenance therapy, or treated with short-acting bronchodilators as rescue medication, or has not been treated with long-acting bronchodilators in the last 3 months.
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 |
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