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

NCT ID: NCT01796730

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-10-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

sequence I

10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days)

Group Type: EXPERIMENTAL

bambuterol

Intervention Type: DRUG

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

Intervention Type: DRUG

sequence II

bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days)

Group Type: EXPERIMENTAL

bambuterol

Intervention Type: DRUG

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

Intervention Type: DRUG

sequence III

placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days)

Group Type: EXPERIMENTAL

bambuterol

Intervention Type: DRUG

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

Intervention Type: DRUG

Interventions

bambuterol

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Bambec, KWD-2183

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

jingping Zheng

Vice Director of Guangzhou Institution of Respiratory Disease

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinping Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Guagnzhou Institute of Respiratory Disease, First affiliated hospital of Guangzhou Medical University

Locations

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Guangzhou Institution of Respiratory Disease (GIRD), The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

References

McDonald CF, Pierce RJ, Thompson PJ, Allen D, Bowler S, Breslin AB, Bowes G, Saunders N, Murree-Allen K, Frith P, Musk AW. Comparison of oral bambuterol and terbutaline in elderly patients with chronic reversible airflow obstruction. J Asthma. 1997;34(1):53-9. doi: 10.3109/02770909709071203.

Reference Type: BACKGROUND

PMID: 9033440 (View on PubMed)

Cazzola M, Calderaro F, Califano C, Di Pema F, Vinciguerra A, Donner CF, Matera MG. Oral bambuterol compared to inhaled salmeterol in patients with partially reversible chronic obstructive pulmonary disease. Eur J Clin Pharmacol. 1999 Jan;54(11):829-33. doi: 10.1007/s002280050561.

Reference Type: BACKGROUND

PMID: 10027655 (View on PubMed)

Other Identifiers

GIRDBAM201201

Identifier Type: -

Identifier Source: org_study_id