Status:
COMPLETED
Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with S...
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 and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 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 :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
793 Patients enrolled
Trial Details
Trial ID
NCT01397890
Start Date
July 1 2011
End Date
June 1 2013
Last Update
March 27 2015
Active Locations (31)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Guangzhou, Guangdong, China
3
Research Site
Changsha, Hunan, China
4
Research Site
Changchun, Jilin, China