NCT00419744CompletedPhase 3
A Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,200
- Locations
- 140
- Primary Endpoint
- Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Study Overview
Brief Summary
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A current clinical diagnosis of COPD with COPD symptoms for more than 2 years
- •Current smoker or smoking history of 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
- •A history of at least 1 COPD exacerbations requiring a course of steroids and/or antibiotics within 1-12 months before the first visit
Exclusion Criteria
- •A history of asthma at or after 18 years of age
- •A history of allergic rhinitis at or after 18 years of age
- •Subjects taking oral steroids
- •Any significant disease or disorder that may jeopardize a subject's safety
Outcomes
Primary Outcomes
Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Time Frame: 12 months
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of Exacerbations Per Subject-year
Time Frame: 12 months
Rate of exacerbations per subject-year
Secondary Outcomes
- Pre-dose Forced Expiratory Volume in 1 Second (FEV1)(12 months)
- Morning Peak Expiratory Flow (PEF)(12 months)
- Evening PEF(12 months)
- Dyspnea Symptom Scores(12 months)
- Use of Rescue Medication(12 months)
- St. George's Respiratory Questionnaire (SGRQ) Score(12 months)
Investigators
Study Sites (140)
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