Effects and Safety of Different Dose of Bambuterol on Chinese COPD Patients
- Registration Number
- NCT01796730
- Lead Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- 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 randomized to receive three treatments (bambuterol 10mg, bambuterol 5 mg and placebo).
- 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 sequences:
* Sequence I: bambuterol 10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) - washout (7 days) - placebo (21 days);
* Sequence II: bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) - washout (7 days) - bambuterol 10mg (21 days) ;
* Sequence III: placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days).
During the treatment period patients will record their adverse events and use of rescue medication (Ipratropium bromide) in a diary. At each visit, pulmonary function tests will be performed. At V2, V4 and V6, forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) are measured at following times: immediately before tablet treatment, and at 0.5, 1, 2, 3, 4, 6, 9, 12hrs after administration of tablets, FEV1 and FVC area under curve (AUC) 0\~12 hours will be analyzed. At V1, V3, V5 and V7, and FVC are measured a time in the morning. Peak expiratory flow rate (PEFR) is measured by Mini-Wright peak flow meter in the morning before treatments. All other data will be evaluated as safety status, and monitoring of adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description sequence II Placebo bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) sequence I Placebo 10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days) sequence III Placebo placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days) sequence II bambuterol bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) sequence I bambuterol 10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days) sequence III bambuterol placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days)
- Primary Outcome Measures
Name Time Method the change in FEV1(L) and FVC(L) pre- and post-treatment during 0 to 3 week, 4 to 7 week and 8 to 11 week The primary endpoints will be the difference in FEV1 as well as FVC between pre-treatment and post-treatment at respective treatment period (ie. Visit 2(0 week) and Visit 3(3 week), Visit 4 (4 week)and Visit 5(7 week), Visit 6 (8 week) and Visit 7(11 week)) .
- Secondary Outcome Measures
Name Time Method difference of AUC(0-12h) FEV1(L) as well as AUC(0-12h) FVC(L) among 3 dose groups at 0, 4, 8 week * AUC FEV1: 0-12h in V2 (0 week), V4 (4 week) and V6 (8 week),
* AUC FVC: 0-12h in V2 (0 week), V4 (4 week) and V6 (8 week),change of PEFR(L/min) during 0 to 3 week, 4 to 7 week and 8 to 11 week difference of Peak flow rate (PEFR) during the treatment period among 3 dose groups
Trial Locations
- Locations (3)
Guangzhou Institution of Respiratory Disease (GIRD), The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Guangzhou First Municipal People's Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China