Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

Quality of Life Clinical Trial

— LUNG-CLEAR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03177889
• Other study ID #: GWJ-TCM-2017
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2020
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Wei-jie Guan, Ph.D.
• Phone: +86-13826042052
• Email: battery203[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult
• Exacerbation
• Quality of Life
• Traditional Chinese Medicine

Intervention

Combination Product:
• Traditional Chinese Medicine (TCM)
Traditional Chinese Medicine plus oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid]; Agastache rugosus 5g, Scutellaria baicalensis 10g, Radix Puerariae 10g, Acorus tatarinowii schott 10g, Fructus Liquidambaris 5g, gypsum 15 g, Rheum officinale 5 g, Folium sennae 5 g, Codonopsis pilosula 10g, Radix Salviae Miltiorrhizae 10g, Lignum millettiae 10 g, Liquiritia glycyrrhiza 10 g Optional formulae: bile arisaema 15g, polygala tenuifolia 15g, Mangnolia officinalis 10g, Fructus aurantii immaturus 10g; Magnetite 15-30g and reddle15-30g

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Guangdong Provincial Hospital of Traditional Chinese Medicine

References & Publications (11)

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. — View 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. — View 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. — View 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. — View Citation

Loukides S, Horvath I, Wodehouse T, Cole PJ, Barnes PJ. Elevated levels of expired breath hydrogen peroxide in bronchiectasis. Am J Respir Crit Care Med. 1998 Sep;158(3):991-4. — View Citation

Pasteur MC, Bilton D, Hill AT; British Thoracic Society Non-CF Bronchiectasis Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65(7):577. doi: 10.1136/thx.2010.142778. — View Citation

Quittner AL, O'Donnell AE, Salathe MA, Lewis SA, Li X, Montgomery AB, O'Riordan TG, Barker AF. Quality of Life Questionnaire-Bronchiectasis: final psychometric analyses and determination of minimal important difference scores. Thorax. 2015 Jan;70(1):12-20. doi: 10.1136/thoraxjnl-2014-205918. Epub 2014 Oct 16. — View Citation

Spinou A, Siegert RJ, Guan WJ, Patel AS, Gosker HR, Lee KK, Elston C, Loebinger MR, Wilson R, Garrod R, Birring SS. The development and validation of the Bronchiectasis Health Questionnaire. Eur Respir J. 2017 May 11;49(5). pii: 1601532. doi: 10.1183/13993003.01532-2016. Print 2017 May. — View Citation

Tsang KW, Chan K, Ho P, Zheng L, Ooi GC, Ho JC, Lam W. Sputum elastase in steady-state bronchiectasis. Chest. 2000 Feb;117(2):420-6. — View 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 — View Citation

Zheng J, Zhong N. Normative values of pulmonary function testing in Chinese adults. Chin Med J (Engl). 2002 Jan;115(1):50-4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes in sputum hydrogen peroxide level at month 6 compared with baseline	changes in sputum hydrogen peroxide level at month 6 compared with baseline	6 months
Other	changes in sputum catalase activity at month 6 compared with baseline	changes in sputum catalase activity at month 6 compared with baseline	6 months
Other	changes in sputum total antioxidant capacity at month 6 compared with baseline	changes in sputum total antioxidant capacity at month 6 compared with baseline	6 months
Other	changes in airway resistance measured at 5 Hz at month 6 compared with baseline	changes in airway resistance measured at 5 Hz at month 6 compared with baseline	6 months
Other	changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline	changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline	6 months
Other	changes in sputum microbiota composition at month 6 compared with baseline	changes in sputum microbiota composition at month 6 compared with baseline	6 months
Other	Changes in AX at month 6 compared with baseline	Changes in AX at month 6 compared with baseline	6 months
Other	Changes in sputum superoxide dismutase activity at month 6 compared with baseline	Changes in sputum superoxide dismutase activity at month 6 compared with baseline	6 months
Primary	Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline	Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline	6 months
Secondary	the frequency of bronchiectasis exacerbation	the frequency of bronchiectasis exacerbation	6 months
Secondary	the time to the first bronchiectasis exacerbation	the time to the first bronchiectasis exacerbation	6 months
Secondary	changes in forced expiratory volume in one second at month 6 compared with baseline	changes in forced expiratory volume in one second at month 6 compared with baseline	6 months
Secondary	24-hour sputum volume at month 6 compared with baseline	24-hour sputum volume at month 6 compared with baseline	6 months
Secondary	changes in sputum purulence score at month 6 compared with baseline	changes in sputum purulence score at month 6 compared with baseline	6 months
Secondary	the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline	the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline	6 months