Status:
COMPLETED
Effects and Safety of Different Dose of Bambuterol on Chinese COPD Patients
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
Nanfang Hospital, Southern Medical University
Guangzhou First People's Hospital
Conditions:
COPD
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind, 3-crossover trial with a 7-days washout baseline period followed by three treatment periods of 21-days each performed in patients with COPD. Patients will be random...
Detailed Description
Patients with COPD who meet the inclusion criteria will enter the 7-days washout baseline period. After the baseline period, patients will be randomly assigned to one of the following treatment sequen...
Eligibility Criteria
Inclusion
- COPD, the disease is under a stable phase
- Giving written informed consent
- Age 40 - 80 years (both inclusive)
- Chinese ethnicity
- 30% of predicated normal ≤Post bronchodilator FEV1 ≤ 70% of predicated normal
- Post bronchodilator FEV1/FVC ≤ 70% (Note: post bronchodilator FEV1 will be tested 20-30 minutes after Salbutamol is used (inhaled via metered dose inhaler (MDI) and spacer).
Exclusion
- COPD acute exacerbation 4 weeks prior to the enrollment
- Patients with a history of asthma, allergic rhinitis, atopy
- Use of disallowed drugs
- Clinically relevant abnormal laboratory values suggesting an undiagnosed disease requiring further clinical evaluation (as assessed by the Investigator)
- Severe psychiatric or neurological disorders
- Congestive heart failure severity grade IV according to New York Heart Association (NYHA)
- Haemodynamically significant cardiac arrhythmias or heart valve deformations
- CT or X-ray findings indicating an acute pulmonary disease other than COPD (e.g. tuberculosis, severe bronchiectasis, tumors)
- Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy)
- Severe acute infectious diseases (e.g. tuberculosis or acute hepatitis)
- Any diagnosis of a malignant disease (except basal cell carcinoma) within 5 years before trial start
- Alcohol or drug abuse within the past year
- Suspected hypersensitivity to the Bambuterol or ingredients thereof, or any other contraindication for the use thereof
- Pregnancy, breast feeding, planned oocyte donation or oocyte implantation
- Participation in another trial (use of investigational product) within 30 days preceding the baseline visit V1 or re-entry of patients previously enrolled in this trial
- Suffering from any concomitant disease that might interfere with trial procedures or evaluations
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01796730
Start Date
February 1 2013
End Date
October 1 2014
Last Update
March 17 2015
Active Locations (3)
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1
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510000
2
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
3
Guangzhou Institution of Respiratory Disease (GIRD), The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120