Clinical trial NCT03177889: Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis
Official title: Efficacy and Safety of Lung Dispersing, Turbid Descending and Gut Clearing Decoction on Clinically Stable Bronchiectasis (LUNG-CLEAR): A Multicenter, Randomized, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis Adult
Traditional Chinese Medicine
Quality of Life
Exacerbation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2017-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Here, the investigators will explore the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.

Detailed description: Bronchiectasis is a chronic airway disease which confers significant healthcare burden, with limited therapeutic approaches. From the perspective of traditional Chinese medicine, congenital insufficiency of the lung, spleen and kidney, when coupled with external injury or mood impairment, may collectively contribute to bronchiectasis pathogenesis due to heat trapping in the phlems, congestion of wind evils and stagnation of blood. Symptomatic treatment may be effective and safe for ameliorating respiratory symptoms and hindering disease progression of bronchiectasis. Here, the investigators have explored the Lung Dispersing, Turbid Descending and Gut Clearing Decoction (LTGD) which targets at expelling the wind evil in patients with bronchiectasis. The investigators sought to conduct a multicenter, randomized cross-over trial which investigates the efficacy and safety of LTGD on clinically stable bronchiectasis.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 75 years;
* remained clinically stable (respiratory symptoms and lung function parameters not exceeding normal daily variations) for 4 consecutive weeks;
* no acute upper respiratory tract infections within 4 weeks;
* 1 or more BEs within the previous 2 years

Exclusion Criteria:

* Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction);
* Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis;
* Concomitant chronic obstructive pulmonary disease as the predominant diagnosis;
* Treatment with inhaled, oral or systemic antibiotics within 4 weeks;
* Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation;
* Females during lactation or pregnancy;
* Poor understanding or failure to properly operate the instrument;
* Participation in other clinical trials within 3 months.

Primary outcomes:
measure: Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline
timeFrame: 6 months
Secondary outcomes:
measure: the frequency of bronchiectasis exacerbation
timeFrame: 6 months
measure: the time to the first bronchiectasis exacerbation
timeFrame: 6 months
measure: changes in forced expiratory volume in one second at month 6 compared with baseline
timeFrame: 6 months
measure: 24-hour sputum volume at month 6 compared with baseline
timeFrame: 6 months
measure: changes in sputum purulence score at month 6 compared with baseline
timeFrame: 6 months
measure: the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline
timeFrame: 6 months
Other outcomes:
measure: changes in sputum hydrogen peroxide level at month 6 compared with baseline
timeFrame: 6 months
measure: changes in sputum catalase activity at month 6 compared with baseline
timeFrame: 6 months
measure: changes in sputum total antioxidant capacity at month 6 compared with baseline
timeFrame: 6 months
measure: changes in airway resistance measured at 5 Hz at month 6 compared with baseline
timeFrame: 6 months
measure: changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline
timeFrame: 6 months
measure: changes in sputum microbiota composition at month 6 compared with baseline
timeFrame: 6 months
measure: Changes in AX at month 6 compared with baseline
timeFrame: 6 months
measure: Changes in sputum superoxide dismutase activity at month 6 compared with baseline
timeFrame: 6 months
Locations:
Study officials:
affiliation: First Affiliated Hospital of Guangzhou Medical University
name: Wei-jie Guan, MD
role: STUDY_CHAIR
References:
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citation: Horvath I, Loukides S, Wodehouse T, Kharitonov SA, Cole PJ, Barnes PJ. Increased levels of exhaled carbon monoxide in bronchiectasis: a new marker of oxidative stress. Thorax. 1998 Oct;53(10):867-70. doi: 10.1136/thx.53.10.867.
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citation: Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Sputum bacteriology in steady-state bronchiectasis in Guangzhou, China. Int J Tuberc Lung Dis. 2015 May;19(5):610-9. doi: 10.5588/ijtld.14.0613.
citation: Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Gu YY, Liu GH, Li HM, Chen RC, Zhong NS. Sputum matrix metalloproteinase-8 and -9 and tissue inhibitor of metalloproteinase-1 in bronchiectasis: clinical correlates and prognostic implications. Respirology. 2015 Oct;20(7):1073-81. doi: 10.1111/resp.12582. Epub 2015 Jun 30.
citation: Zhang ZM, Ren PH, Wu ZJ, Zhang DP, Xie WJ. Personalized alternative therapy of intractable bronchiectasis-induced hemoptysis in a patient: syndrome differentiation and treatment according to individual physique category. J Thorac Dis. 2013 Jun;5(3):E115-7. doi: 10.3978/j.issn.2072-1439.2013.06.26. No abstract available.
citation: Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Impulse oscillometry in adults with bronchiectasis. Ann Am Thorac Soc. 2015 May;12(5):657-65. doi: 10.1513/AnnalsATS.201406-280OC.