The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.
Bronchiectasis is a common and frequently occurring respiratory disease, with more hospitalization rate and mortality, poor quality of life and heavy financial burden. The main clinical manifestations are persistent or recurrent cough, expectoration, sometimes accompanied by hemoptysis, which can cause respiratory dysfunction and chronic pulmonary heart disease. There are some randomized controlled trials of TCM for bronchiectasis, and have the effect in the treatment of bronchiectasis, reducing the number of acute aggravation and alleviating dyspnea. However, some TCM interventions lack comprehensive syndrome differentiation and the placebo control. This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy to evaluate the effectiveness of TCM on patients with clinically stable bronchiectasis. 216 subjects will be randomly assigned to one therapies (TCM treatments based on syndrome differentiation) and the other therapy (placebo of TCM treatment) for 24 weeks. After the treatment period, the subjects will be followed up for 24 weeks. The primary outcomes include the frequency of bronchiectasis exacerbation, and the secondary outcomes include quality of life (SGRQ, LCQ, QOL-B), pulmonary function, safety observation index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given placebo Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
The frequency of bronchiectasis exacerbation
The bronchiectasis exacerbations often result in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of bronchiectasis exacerbations over time.
Time frame: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.
The time to the first bronchiectasis exacerbation
Time frame: Week 24 of the treatment phase.
Changes in Forced expiratory volume in one second
Forced expiratory volume in one second (FEV1)is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function.
Time frame: Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
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According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given placebo Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.