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A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Bangalore, Karnataka, India
Research Site
Mysore, Karnataka, India
Research Site
Trivandrum, Kerala, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Nagpur, Maharashtra, India
Research Site
New Delhi, National Capital Territory of Delhi, India
Research Site
Coimbatore, Tamil Nadu, India
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Okazaki, Aichi-ken, Japan
Research Site
Seto, Aichi-ken, Japan
Start Date
January 1, 2010
Primary Completion Date
March 1, 2011
Completion Date
March 1, 2011
Last Updated
October 25, 2012
1,293
ACTUAL participants
Budesonide/formoterol (Symbicort Turbuhaler)
DRUG
Formoterol (Oxis Turbuhaler)
DRUG
Lead Sponsor
AstraZeneca
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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