To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 4, 2017

Primary Completion Date

December 3, 2018

Study Completion Date

December 3, 2018

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
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."

DRUG

Standard of Care

Brochodilators

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

QuintilesIMS, Inc.

UNKNOWN

lead

AstraZeneca

INDUSTRY