Clinical trial NCT05459805: Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine
Official title: Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough Variant Asthma
Keywords: cough variant asthma
traditional Chinese medicine
clinical trial
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Xin Hua Hospital of Zhejiang Province
name: Hangzhou Hospital of Traditional Chinese Medicine
name: Affiliated Wenling Hospital of Wenzhou Medical University
First posted: 2022-07-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: total effective rate calculated by the Cough-related Symptom Scale
timeFrame: week 8
measure: total effective rate calculated by the Cough-related Symptom Scale
timeFrame: week 32
Secondary outcomes:
measure: change from baseline in Cough-related Symptom Scale
timeFrame: baseline and week 8 ,baseline and week 32
measure: change from baseline in Cough severity visual analogue scale
timeFrame: baseline and week 8 ,baseline and week 32
measure: change from baseline in Leicester Cough Questionnaire
timeFrame: baseline and week 8 ,baseline and week 32
measure: change from baseline in Pulmonary function
timeFrame: baseline and week 8 ,baseline and week 32
measure: CVA recurrence rate from week 8 to week 32
timeFrame: week 32
measure: the ratio of progressing to typical asthma from week 8 to week 32
timeFrame: week 32
measure: change from baseline in fractional exhaled nitric oxide
timeFrame: baseline and week 8 ,baseline and week 32
measure: change from baseline in Serum IgE
timeFrame: baseline and week 8 ,baseline and week 32
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Hospital of Traditional Chinese Medicine
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
city: Hangzhou
country: China
facility: Xin Hua Hospital of Zhejiang Province
city: Taizhou
country: China
facility: The First People's Hospital of Wenling
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Junchao Yang
role: STUDY_CHAIR
References: