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Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis (LUNG-CLEAR)

Primary Purpose

Bronchiectasis Adult, Traditional Chinese Medicine, Quality of Life

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Traditional Chinese Medicine (TCM)

About this trial

This is an interventional treatment trial for Bronchiectasis Adult

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Usual treatment

TCM treatment

Arm Description

oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid]

Traditional Chinese Medicine plus oral mucolytics (described above); 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

Outcomes

Primary Outcome Measures

Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

Secondary Outcome Measures

the frequency of bronchiectasis exacerbation

the time to the first bronchiectasis exacerbation

changes in forced expiratory volume in one second at month 6 compared with baseline

24-hour sputum volume at month 6 compared with baseline

changes in sputum purulence score at month 6 compared with baseline

the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline

Full Information

NCT ID

NCT03177889

First Posted

June 4, 2017

Last Updated

February 8, 2020

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03177889

Brief Title

Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 31, 2021 (Anticipated)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual treatment

Arm Type

Sham Comparator

Arm Description

oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid]

Arm Title

TCM treatment

Arm Type

Active Comparator

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

Traditional Chinese Medicine (TCM)

Other Intervention Name(s)

TCM

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

Description

Changes in Bronchiectasis Health Questionnaire scores at month 6 compared with baseline

Time Frame

6 months

Secondary Outcome Measure Information:

Title

the frequency of bronchiectasis exacerbation

Description

the frequency of bronchiectasis exacerbation

Time Frame

6 months

Title

the time to the first bronchiectasis exacerbation

Description

the time to the first bronchiectasis exacerbation

Time Frame

6 months

Title

changes in forced expiratory volume in one second at month 6 compared with baseline

Description

changes in forced expiratory volume in one second at month 6 compared with baseline

Time Frame

6 months

Title

24-hour sputum volume at month 6 compared with baseline

Description

24-hour sputum volume at month 6 compared with baseline

Time Frame

6 months

Title

changes in sputum purulence score at month 6 compared with baseline

Description

changes in sputum purulence score at month 6 compared with baseline

Time Frame

6 months

Title

the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline

Description

the proportion of patients isolated with Pseudomonas aeruginosa at month 6 compared with baseline

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

changes in sputum hydrogen peroxide level at month 6 compared with baseline

Description

changes in sputum hydrogen peroxide level at month 6 compared with baseline

Time Frame

6 months

Title

changes in sputum catalase activity at month 6 compared with baseline

Description

changes in sputum catalase activity at month 6 compared with baseline

Time Frame

6 months

Title

changes in sputum total antioxidant capacity at month 6 compared with baseline

Description

changes in sputum total antioxidant capacity at month 6 compared with baseline

Time Frame

6 months

Title

changes in airway resistance measured at 5 Hz at month 6 compared with baseline

Description

changes in airway resistance measured at 5 Hz at month 6 compared with baseline

Time Frame

6 months

Title

changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline

Description

changes in Quality-of-life-bronchiectasis questionnaire score at month 6 compared with baseline

Time Frame

6 months

Title

changes in sputum microbiota composition at month 6 compared with baseline

Description

changes in sputum microbiota composition at month 6 compared with baseline

Time Frame

6 months

Title

Changes in AX at month 6 compared with baseline

Description

Changes in AX at month 6 compared with baseline

Time Frame

6 months

Title

Changes in sputum superoxide dismutase activity at month 6 compared with baseline

Description

Changes in sputum superoxide dismutase activity at month 6 compared with baseline

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-jie Guan, Ph.D.

Phone

+86-13826042052

battery203@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhi-min Zhang, M.D.

Phone

+86-18928868345

zhangzhimin51666@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-jie Guan, MD

Organizational Affiliation

First Affiliated Hospital of Guangzhou Medical University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

20627912

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. No abstract available.

Results Reference

background

PubMed Identifier

9731036

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. doi: 10.1164/ajrccm.158.3.9710031.

Results Reference

background

PubMed Identifier

10193374

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.

Results Reference

background

PubMed Identifier

10669685

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. doi: 10.1378/chest.117.2.420.

Results Reference

background

PubMed Identifier

25323621

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.

Results Reference

background

PubMed Identifier

28495688

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):1601532. doi: 10.1183/13993003.01532-2016. Print 2017 May.

Results Reference

background

PubMed Identifier

11930658

Citation

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

Results Reference

background

PubMed Identifier

25868032

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.

Results Reference

background

PubMed Identifier

26122009

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.

Results Reference

background

PubMed Identifier

23825784

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.

Results Reference

result

PubMed Identifier

25654540

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.

Results Reference

result

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Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

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