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

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.

Study Overview

• Status: Recruiting
• Conditions: Cough Variant Asthma
• Intervention / Treatment: Drug: Chinese Herb

• Study Type: Observational
• Enrollment (Anticipated): 164

Contacts and Locations

• Study Contact: Name: Junchao Yang; Phone Number: +86 13858036093; Email: yangjunchaozj@163.com

Study Locations

• China
  • Hangzhou, China
    • Not yet recruiting
    • Hangzhou hospital of traditional Chinese medicine
    • Contact: Jingjing Hu; Phone Number: +86 15088648189; Email: a360081592@126.com
  • Hangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhejiang Chinese Medical University
    • Contact: Junchao Yang; Phone Number: +86 13858036093; Email: yangjunchaozj@163.com
  • Hangzhou, China
    • Not yet recruiting
    • Xin Hua Hospital of Zhejiang Province
    • Contact: Minjing Li; Phone Number: +86 13588420329; Email: lmjmaodou@126.com
  • Taizhou, China
    • Not yet recruiting
    • The First People's Hospital of Wenling
    • Contact: Junfeng Chen; Phone Number: +86 15058600178; Email: junfengsophie@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study is being performed in four centers, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xin Hua Hospital of Zhejiang Province, Hangzhou Hospital of Traditional Chinese Medicine and The First People's Hospital of Wenling, in Zhejiang. Participants screening is completed by specialists with a background in Respiratory.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort 1; those receive treatment with Chinese herbal medicine	Drug: Chinese Herb; 200ml, bid, for 8 weeks
cohort 2; those receive treatment without Chinese herbal medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
CVA recurrence rate from week 8 to week 32	CVA recurrence rate is defined as the occurance rate of similar cough which conforms to CVA diagnosis criteria during 6-month observation.	week 32
the ratio of classic asthma turning from CVA from week 8 to week 32	the ratio of classic asthma turning from CVA is characterized as the ratio of participants who turning from CVA into classic asthma based on Guidelines for bronchial asthma prevent and management (2020 edition) during 6-month observation.	week 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in Cough-related Symptom Scale	This scale consists of two parts. Question1-5 come from Chinese national guideline on diagnosis and management of cough (2021) to evaluate the symptom of cough. Question6-10 are some accompanying performances, including cough-stimulated factors like wind, cold air, smoking etc, sputum, sensations of "persistent tickling", "thirsty", "Qi inversion" in throat.	baseline and week 8
change from baseline in Cough-related Symptom Scale	This scale consists of two parts. Question1-5 come from Chinese national guideline on diagnosis and management of cough (2021) to evaluate the symptom of cough. Question6-10 are some accompanying performances, including cough-stimulated factors like wind, cold air, smoking etc, sputum, sensations of "persistent tickling", "thirsty", "Qi inversion" in throat.	baseline and week 32
change from baseline in Cough severity visual analogue scale	Cough severity visual analogue scale (VAS) is used to record participants' assessments of cough severity. It is shown as a 0-mm to 100-mm liner scale ranging from "no cough" to "severe cough". The bigger score represents more severe cough.	baseline and week 8
change from baseline in Cough severity visual analogue scale	Cough severity visual analogue scale (VAS) is used to record participants' assessments of cough severity. It is shown as a 0-mm to 100-mm liner scale ranging from "no cough" to "severe cough". The bigger score represents more severe cough.	baseline and week 32
change from baseline in Leicester Cough Questionnaire	Leicester Cough Questionnaire, as a useful tool in clinical trial, consists of 19 items which is a repeatable, valid self-evaluated quality of life measure of chronic cough and responsive to change .	baseline and week 8
change from baseline in Leicester Cough Questionnaire	Leicester Cough Questionnaire, as a useful tool in clinical trial, consists of 19 items which is a repeatable, valid self-evaluated quality of life measure of chronic cough and responsive to change .	baseline and week 32
change from baseline in Pulmonary function	Pulmonary function test reveals some details of a patient's condition in respiratory function, like forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, peak expiratory flow (PEF), forced expiratory flow 25% (FEF25), forced expiratory flow 75% (FEF75), forced expiratory flow between 25% and 75% of forced vital capacity (FEF(25-75)) etc.	baseline and week 8
change from baseline in Pulmonary function	Pulmonary function test reveals some details of a patient's condition in respiratory function, like forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, peak expiratory flow (PEF), forced expiratory flow 25% (FEF25), forced expiratory flow 75% (FEF75), forced expiratory flow between 25% and 75% of forced vital capacity (FEF(25-75)) etc.	baseline and week 32

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in fractional exhaled nitric oxide	Nitric oxide (NO) is produced by inducible nitric oxide synthase (iNOS) in airway epithelial cells and FENO is associated with eosinophilic airway inflammation which usually indicates the sensitivity to ICS.	baseline and week 8 ,baseline and week 32
change from baseline in Serum IgE	IgE is linked to its ability to affect several immune and structural cells involved in allergic asthma.	baseline and week 8 ,baseline and week 32

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Collaborators: Xin Hua Hospital of Zhejiang Province; Hangzhou Hospital of Traditional Chinese Medicine; The First People's Hospital of Wenling
• Investigators: Study Chair: Junchao Yang, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: clinical trial; traditional Chinese medicine; cough variant asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Cough
• Other Study ID Numbers: 2022ZZ011; ChiCTR2100048636 (Registry Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: ndividual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No