Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Lung Dispersing, Turbid Descending and Gut Clearing Decoction on Clinically Stable Bronchiectasis (LUNG-CLEAR): A Multicenter, Randomized, Cross-over Trial

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

Intervention / Treatment
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* Combination Product: Traditional Chinese Medicine (TCM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Usual treatment<br>oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid] | Combination Product: Traditional Chinese Medicine (TCM)<br>* 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<br>* Other names: TCM;|
| Active Comparator: TCM treatment<br>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 | Combination Product: Traditional Chinese Medicine (TCM)<br>* 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<br>* Other names: TCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of bronchiectasis exacerbation | the frequency of bronchiectasis exacerbation | 6 months | 
| the time to the first bronchiectasis exacerbation | the time to the first bronchiectasis exacerbation | 6 months | 
| 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 | 
| 24-hour sputum volume at month 6 compared with baseline | 24-hour sputum volume at month 6 compared with baseline | 6 months | 
| changes in sputum purulence score at month 6 compared with baseline | changes in sputum purulence score at month 6 compared with baseline | 6 months | 
| 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 |