Overview

This trial is active, not recruiting.

Condition copd
Treatments bambuterol, placebo
Phase phase 4
Sponsor The First Affiliated Hospital of Guangzhou Medical University
Collaborator Nanfang Hospital of Southern Medical University
Start date February 2013
End date April 2015
Trial size 57 participants
Trial identifier NCT01796730, GIRDBAM201201

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days)
bambuterol Bambec, KWD-2183
Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days.
placebo
(Experimental)
bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days)
bambuterol Bambec, KWD-2183
Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days.
placebo
(Experimental)
placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days)
bambuterol Bambec, KWD-2183
Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days.
placebo

Primary Outcomes

Measure
the change in FEV1(L) and FVC(L)
time frame: pre- and post-treatment during 0 to 3 week, 4 to 7 week and 8 to 11 week

Secondary Outcomes

Measure
difference of AUC(0-12h) FEV1(L) as well as AUC(0-12h) FVC(L) among 3 dose groups
time frame: at 0, 4, 8 week
change of PEFR(L/min)
time frame: during 0 to 3 week, 4 to 7 week and 8 to 11 week

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title A 12-week, Double-blind, Multicenter, 3-crossover, Placebo Controlled and Randomized Trial to Investigate the Efficacy and Safety of 10mg and 5mg Bambuterol Tablets Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Principal investigator Jinping Zheng, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by The First Affiliated Hospital of Guangzhou Medical University.