Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine

The First Affiliated Hospital of Zhejiang Chinese Medical University

Status: Enrolling

Conditions: Cough Variant Asthma

Treatments: Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA); Drug: traditional chinese medicine Xuanfei-Zhike formula

Study type: Interventional

Funder types: Other

Identifiers

NCT05459805

ChiCTR2100048636 (Registry Identifier)

2022ZZ011

Details and patient eligibility

About

To explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of Chinese and Western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and Western medicine for cough variant asthma. This is a multi-center, non-randomized, prospective cohort study. This study started in March 2022 and is going on now. On an informed consent basis, a cohort of 164 patients with diagnosis of CVA are engaged. All patients will receive 8-week treatment (ICS/LABA plus Chinese herbal medicine for trial group while ICS/LABA only for control group) and be observed in next 24 weeks. Patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.The feasibility and correctness of the study will be supervised by two supervisors. To ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. Additionally, incentives are used to appreciate participants for their cooperation.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. conform to diagnosis of CVA;
2. 18 years≤age≤65 years;
3. agree to participant in this trial.

Exclusion criteria

1. comorbidity of respiratory and pulmonary infections;
2. history of mental illness;
3. comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases;
4. participants of other clinical trials who may make a difference in our trial;
5. treatment with other Chinese herb.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

group 1

Experimental group

Description:

those receive ICS/LABA plus traditional Chinese medicine

Treatment:

Drug: traditional chinese medicine Xuanfei-Zhike formula

Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)

group 2

Active Comparator group

Description:

those receive ICS/LABA alone

Treatment:

Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)