Effects and Safety of Different Dose of Bambuterol on Chinese COPD Patients

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: Guangzhou First Municipal People’s Hospital; Guangzhou First People's Hospital; Nanfang Hospital of Southern Medical University
• Treatments: Bambuterol; Terbutaline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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