Status:
COMPLETED
Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.
Detailed Description
Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, ...
Eligibility Criteria
Inclusion
- Signed and dated informed consent
- Men or women patients ≥ 40 years of age
- Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
- Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
- Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
Exclusion
- A history of asthma and seasonal allergic rhinitis before 40 years of age
- Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period
- Patients with relevant cardiovascular disorder judged by the investigator
- Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
- Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
581 Patients enrolled
Trial Details
Trial ID
NCT01415518
Start Date
September 1 2011
End Date
December 1 2012
Last Update
July 9 2019
Active Locations (21)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Foshan, Guangdong, China
3
Research Site
Guangzhou, Guangdong, China
4
Research Site
Zhongshan, Guangdong, China