effects and safety of different dose of bambuterol on chinese copd patients

Conditions: COPD

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).

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.

Eligibility 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

Keywords: efficacy safety bambuterol tablets copd