A Phase 4 interventional study of bambuterol and Placebo in COPD, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Completed at 3 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 4, Interventional, and Treatment
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:
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.
The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10mg (21 days) -washout (7 days) - bambuterol 5mg (21 days) -washout (7 days) -placebo (21 days)
Drug: bambuterol · Drug: Placebo
bambuterol 5mg (21 days) -washout (7 days) - placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days)
Drug: bambuterol · Drug: Placebo
placebo (21 days) -washout (7 days) - bambuterol 10mg (21 days) - washout (7 days) - bambuterol 5mg (21 days)
Drug: bambuterol · Drug: Placebo
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
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)) .
Time frame: pre- and post-treatment during 0 to 3 week, 4 to 7 week and 8 to 11 week
difference of AUC(0-12h) FEV1(L) as well as AUC(0-12h) FVC(L) among 3 dose groups
* 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),
Time frame: at 0, 4, 8 week
change of PEFR(L/min)
difference of Peak flow rate (PEFR) during the treatment period among 3 dose groups
Time frame: during 0 to 3 week, 4 to 7 week and 8 to 11 week
use of rescue medication
•difference of use of rescue medication (Ipratropium bromide) during the treatment period among 3 dose groups
Time frame: during 0 to 3week,4 to 7 week and 8 to 11 week
The Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI)
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.
Time frame: BDI at 0, 4 and 8 week, TDI at 3, 7 and 11 week
Tremor, Palpitation
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.
Time frame: up to 11 weeks
electrocardiogram (ECG)
Electrocardiogram (ECG) will be assessed at all visits
Time frame: at -1,0,3,4,7,8,11 week
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University