A Chronic Obstructive Pulmonary Disease (COPD) Trial Investigating Roflumilast on Safety and Effectiveness in China, Hong Kong and Singapore:
NCT ID: NCT01313494
Last Updated: 2017-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
626 participants
INTERVENTIONAL
2011-03-31
2012-05-31
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
DOUBLE
Study Groups
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Roflumilast
Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
Roflumilast
Roflumilast tablets
Salbutamol
Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.
Placebo
Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
Placebo
Placebo tablets
Salbutamol
Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.
Interventions
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Roflumilast
Roflumilast tablets
Placebo
Placebo tablets
Salbutamol
Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.
Eligibility Criteria
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Inclusion Criteria
* Chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2009
* Chinese or Malay or Indian ethnicity
* History of chronic obstructive pulmonary disease symptoms for at least 12 months prior to baseline visit V0
* Forced expiratory volume in the first second/ Forced vital capacity (FEV1/FVC) ratio (post-bronchodilator) \< 70%
* Forced expiratory volume in the first second (FEV1) (post-bronchodilator) \< 50 % of predicted
* Former smoker (defined as: smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years
Exclusion Criteria
* Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
* History of asthma diagnosis in patients \< 40 years of age or relevant lung disease other than COPD
* Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
* Known alpha-1-antitrypsin deficiency
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Beijing, , China
Changsha, , China
Chengdu, , China
Chongqing, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Nanjing, , China
Nanning, , China
Qingdao, , China
Shanghai, , China
Shenyang, , China
Shijiazhuang, , China
Hong Kong, , Hong Kong
Singapore, , Singapore
Countries
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References
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Zheng J, Yang J, Zhou X, Zhao L, Hui F, Wang H, Bai C, Chen P, Li H, Kang J, Brose M, Richard F, Goehring UM, Zhong N. Roflumilast for the treatment of COPD in an Asian population: a randomized, double-blind, parallel-group study. Chest. 2014 Jan;145(1):44-52. doi: 10.1378/chest.13-1252.
Other Identifiers
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U1111-1133-6304
Identifier Type: REGISTRY
Identifier Source: secondary_id
RO-2455-301-RD
Identifier Type: -
Identifier Source: org_study_id
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