Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT ID: NCT01415518
Last Updated: 2019-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
581 participants
INTERVENTIONAL
2011-09-01
2012-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Drug: Budesonide/formoterol (Symbicort Turbuhaler
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
2
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Interventions
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Drug: Budesonide/formoterol (Symbicort Turbuhaler
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
Drug: ipratropium (AtroventTM)
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
theophylline SR
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel Chen
Role: STUDY_CHAIR
AstraZeneca Singapore Pte Ltd
Locations
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Research Site
Beijing, Beijing Municipality, China
Research Site
Foshan, Guangdong, China
Research Site
Guangzhou, Guangdong, China
Research Site
Zhongshan, Guangdong, China
Research Site
Haikou, Hainan, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Tangshan, Hebei, China
Research Site
Zhengzhou, Henan, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Shenyang, Liaoning, China
Research Site
Qingdao, Shandong, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Chengdu, , China
Research Site
Chongqin, , China
Research Site
Dalian, , China
Research Site
Ha'er BING, , China
Research Site
Hohhot, , China
Countries
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Related Links
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Other Identifiers
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D589BL00022
Identifier Type: -
Identifier Source: org_study_id
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