A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
40 Years
N/A
Both
Chronic Obstructive Pulmonary Disease, COPD
Trial Information
A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
Inclusion Criteria:
- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1
<=50% of PN
Exclusion Criteria:
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis,
significant or unstable cardiovascular disorder
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Outcome Description:
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Outcome Time Frame:
Baseline to 12 weeks
Safety Issue:
No
Principal Investigator
Tomas Andersson, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca R&D Lund
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
D5892C00015
NCT ID:
NCT00496470
Start Date:
May 2007
Completion Date:
June 2008
Related Keywords:
- Chronic Obstructive Pulmonary Disease, COPD
- Chronic Obstructive Pulmonary Disease, COPD
- Lung Diseases
- Respiration Disorders
- Pulmonary Disease, Chronic Obstructive
- Lung Diseases, Obstructive
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