Clinical trial NCT03443531: Effects of Traditional Chinese Medicine on Bronchiectasis Patients
Official title: Effects of Traditional Chinese Medicine on Bronchiectasis Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bronchiectasis
Keywords: Bronchiectasis
Traditional Chinese Medicine
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of clinically stable bronchiectasis
* Age between 18 and 80 years
* Syndrome differentiation meets criteria of syndrome of Qi deficiency of lung and phlegm-turbidity obstructing the lung, syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung
* Without participations in other interventional trials in the previous one month
* With the informed consent signed

Exclusion Criteria:

* Current respiratory disorders other than bronchiectasis (e.g. COPD,bronchial asthma, lung cancer,active tuberculosis, Interstitial lung disease, pulmonary thromboembolic, or Other patients who have an impact on the observation of disease)
* Patients with severe cardiovascular disease (e.g. Acute myocardial infarction,Acute heart failure)
* Severe liver disease(e.g.Active phase of hepatitis, Cirrhosis, Severe impairment of liver function by portal hypertension)
* Severe renal disease(e.g. renal transplant, dialysis)
* Patients with large hemoptysis in the last month
* Pregnant and lactating women
* Insanity, Dementia, and all kinds of Psychosis
* Smoking patients (Years of smoking10/ package year)
* Participating in other clinical trials with other interventions;
* Allergic to the used medicine.

Primary outcomes:
measure: The frequency of bronchiectasis exacerbation
timeFrame: 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.
Secondary outcomes:
measure: The time to the first bronchiectasis exacerbation
timeFrame: Week 24 of the treatment phase.
measure: Changes in Forced expiratory volume in one second
timeFrame: Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
Other outcomes:
measure: Changes in St Georges respiratory questionnaire scores
timeFrame: Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in the Leicester Cough questionnaire scores
timeFrame: Changes in the LCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in the Quality of Life-Bronchiectasis scores
timeFrame: Changes in the Qol-B scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Locations:
Study officials:
affiliation: Henan University of Traditional Chinese Medicine
name: Jiansheng Li, Doctor
role: STUDY_CHAIR
References: