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

NCT05459805 | Unknown

• 2 other identifiers: 2022ZZ011ChiCTR2100048636
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 4

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.

Conditions

Cough Variant Asthma

Keywords

cough variant asthma; traditional Chinese medicine; clinical trial

Outcome Measures

Primary Outcomes (2)

• total effective rate calculated by the Cough-related Symptom Scale

  Cough-related Symptom Scale is specially designed for this trial. Question1-5 in CSS comes from Chinese national guideline on diagnosis and management of cough (2021) and the rest questions are set based on clinical experience and other study . Total effective rate can be directly reflected in Efficacy Index (EI) which set by National Medical Products Administration .

  week 8

• total effective rate calculated by the Cough-related Symptom Scale

  Cough-related Symptom Scale is specially designed for this trial. Question1-5 in CSS comes from Chinese national guideline on diagnosis and management of cough (2021) and the rest questions are set based on clinical experience and other study . Total effective rate can be directly reflected in Efficacy Index (EI) which set by National Medical Products Administration .

  week 32

Secondary Outcomes (8)

• change from baseline in Cough-related Symptom Scale

  baseline and week 8 ,baseline and week 32

• change from baseline in Cough severity visual analogue scale

  baseline and week 8 ,baseline and week 32

• change from baseline in Leicester Cough Questionnaire

  baseline and week 8 ,baseline and week 32

• change from baseline in Pulmonary function

  baseline and week 8 ,baseline and week 32

• CVA recurrence rate from week 8 to week 32

  week 32

Study Arms (2)

group 1

EXPERIMENTAL

those receive ICS/LABA plus traditional Chinese medicine

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

group 2

ACTIVE COMPARATOR

those receive ICS/LABA alone

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

Interventions

traditional chinese medicine Xuanfei-Zhike formula DRUG

200ml, bid, for 8 weeks

group 1

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

one suction, q12h, for 8 weeks

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• conform to diagnosis of CVA;
• years≤age≤65 years;
• agree to participant in this trial.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Xin Hua Hospital of Zhejiang Province: collaborator
• Hangzhou Hospital of Traditional Chinese Medicine: collaborator
• Affiliated Wenling Hospital of Wenzhou Medical University: collaborator

Study Sites (4)

Hangzhou Hospital of Traditional Chinese Medicine

Hangzhou, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, China

RECRUITING

Xin Hua Hospital of Zhejiang Province

Hangzhou, China

NOT YET RECRUITING

The First People's Hospital of Wenling

Taizhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Cough-Variant Asthma

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Junchao Yang

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY CHAIR

Central Study Contacts

Junchao Yang

CONTACT

+86 13858036093; yangjunchaozj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 15, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our Hospital's data warehouse but without investigator support other than deposited metadata.

Locations

CN (4)