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

NCT01796730 | Completed Phase 4 DMC

• 1 other identifier: GIRDBAM201201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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).

Conditions

COPD

Keywords

efficacy; safety; Bambuterol tablets; COPD

Outcome Measures

Primary Outcomes (1)

• the change in FEV1(L) and FVC(L)

  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)) .

  pre- and post-treatment during 0 to 3 week, 4 to 7 week and 8 to 11 week

Secondary Outcomes (2)

• difference of AUC(0-12h) FEV1(L) as well as AUC(0-12h) FVC(L) among 3 dose groups

  at 0, 4, 8 week

• change of PEFR(L/min)

  during 0 to 3 week, 4 to 7 week and 8 to 11 week

Other Outcomes (4)

• use of rescue medication

  during 0 to 3week,4 to 7 week and 8 to 11 week

• The Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI)

  BDI at 0, 4 and 8 week, TDI at 3, 7 and 11 week

• Tremor, Palpitation

  up to 11 weeks

Study Arms (3)

sequence I

EXPERIMENTAL

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

Drug: bambuterol; Drug: Placebo

sequence II

EXPERIMENTAL

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

Drug: bambuterol; Drug: Placebo

sequence III

EXPERIMENTAL

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

Drug: bambuterol; Drug: Placebo

Interventions

bambuterol 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.

Also known as: Bambec, KWD-2183

sequence I; sequence II; sequence III

Placebo DRUG

sequence I; sequence II; sequence III

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD, the disease is under a stable phase
• Giving written informed consent
• Age 40 - 80 years (both inclusive)
• Chinese ethnicity
• % 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Guangzhou First People's Hospital: collaborator

Study Sites (3)

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

Related Publications (2)

• 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.

  PMID: 9033440 BACKGROUND

• 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.

  PMID: 10027655 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

bambuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinping Zheng, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Guangzhou Institution of Respiratory Disease

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 22, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

CN (3)