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

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ClinicalTrials.gov Identifier: NCT01796730
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : March 17, 2015
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital
Information provided by (Responsible Party):
jingping Zheng, The First Affiliated Hospital of Guangzhou Medical University

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).

Condition or disease Intervention/treatment Phase
COPD Drug: bambuterol Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: sequence I
10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days)
Drug: 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.
Other Name: Bambec, KWD-2183

Drug: Placebo
Experimental: sequence II
bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days)
Drug: 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.
Other Name: Bambec, KWD-2183

Drug: Placebo
Experimental: sequence III
placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days)
Drug: 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.
Other Name: Bambec, KWD-2183

Drug: Placebo



Primary Outcome Measures :
  1. 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 ]
    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)) .


Secondary Outcome Measures :
  1. 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 ]
    • AUC FEV1: 0-12h in V2 (0 week), V4 (4 week) and V6 (8 week),
    • AUC FVC: 0-12h in V2 (0 week), V4 (4 week) and V6 (8 week),

  2. change of PEFR(L/min) [ Time Frame: during 0 to 3 week, 4 to 7 week and 8 to 11 week ]
    difference of Peak flow rate (PEFR) during the treatment period among 3 dose groups


Other Outcome Measures:
  1. use of rescue medication [ Time Frame: during 0 to 3week,4 to 7 week and 8 to 11 week ]
    •difference of use of rescue medication (Ipratropium bromide) during the treatment period among 3 dose groups

  2. The Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI) [ Time Frame: BDI at 0, 4 and 8 week, TDI at 3, 7 and 11 week ]

    The Baseline Dyspnea Index (BDI) will be collected before each treatment period, ie. at visits of 2, 4, 6.

    Transition Dyspnoea Index (TDI) will be collected at the end of each treatment period, ie. at visits of 3, 5, 7.


  3. Tremor, Palpitation [ Time Frame: up to 11 weeks ]
    Difference of frequency and severity of tremor, palpitation and other adverse events among 3 dose groups will be collected and analyzed during the whole study period.

  4. electrocardiogram (ECG) [ Time Frame: at -1,0,3,4,7,8,11 week ]
    Electrocardiogram (ECG) will be assessed at all visits



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796730


Locations
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China, Guangdong
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China, 510000
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Guangzhou Institution of Respiratory Disease (GIRD), The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital
Investigators
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Principal Investigator: Jinping Zheng, MD Guagnzhou Institute of Respiratory Disease, First affiliated hospital of Guangzhou Medical University

Publications:
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Responsible Party: jingping Zheng, Vice Director of Guangzhou Institution of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01796730     History of Changes
Other Study ID Numbers: GIRDBAM201201
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by jingping Zheng, The First Affiliated Hospital of Guangzhou Medical University:
efficacy
safety
Bambuterol tablets
COPD
Additional relevant MeSH terms:
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Terbutaline
Bambuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action