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

July 11, 2022 updated by: The First Affiliated Hospital of Zhejiang Chinese Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Hangzhou, China
        • Not yet recruiting
        • Hangzhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:
      • Hangzhou, China
        • Not yet recruiting
        • Xin Hua Hospital of Zhejiang Province
        • Contact:
      • Taizhou, China
        • Not yet recruiting
        • The First People's Hospital of Wenling
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
total effective rate calculated by the Cough-related Symptom Scale
Time Frame: week 8
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
Time Frame: week 32
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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in Cough-related Symptom Scale
Time Frame: baseline and week 8
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
Time Frame: baseline and week 32
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
Time Frame: baseline and week 8
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
Time Frame: baseline and week 32
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
Time Frame: baseline and week 8
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
Time Frame: baseline and week 32
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
Time Frame: baseline and week 8
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
Time Frame: baseline and week 32
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in fractional exhaled nitric oxide
Time Frame: baseline and week 8 ,baseline and week 32
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
Time Frame: baseline and week 8 ,baseline and week 32
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xin Hua Hospital of Zhejiang Province
Hangzhou Hospital of Traditional Chinese Medicine
The First People's Hospital of Wenling

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Junchao Yang, The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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