Cough Variant AsthmaNCT05459805
Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine
A study testing traditional chinese medicine Xuanfei-Zhike formula and inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) in people with Cough Variant Asthma, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cough Variant Asthma
- What is being tested?
- traditional chinese medicine Xuanfei-Zhike formula and inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- conform to diagnosis of CVA;
- 18 years≤age≤65 years;
- agree to participant in this trial.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou
Jingjing Hu, +86 15088648189, a360081592@126.com
- Recruiting
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou
Junchao Yang, +86 13858036093, yangjunchaozj@163.com
- Not yet recruiting
Xin Hua Hospital of Zhejiang Province
Hangzhou
Minjing Li, +86 13588420329, lmjmaodou@126.com
- Not yet recruiting
The First People's Hospital of Wenling
Taizhou
Junfeng Chen, +86 15058600178, junfengsophie@163.com
About this study
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
- Being tested
- traditional chinese medicine Xuanfei-Zhike formula, inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)
- Keywords
- cough variant asthma, traditional Chinese medicine, clinical trial
- Medical subject headings
- Cough-Variant Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional chinese medicine Xuanfei-Zhike formulaDrug
200ml, bid, for 8 weeks
inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)Drug
one suction, q12h, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | those receive ICS/LABA plus traditional Chinese medicine Receives: 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 Receives: Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: week 32
Secondary outcomes (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.
Measured: baseline and week 8 ,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.
Measured: baseline and week 8 ,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 .
Measured: baseline and week 8 ,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.
Measured: baseline and week 8 ,baseline and 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.
Measured: week 32
the ratio of progressing to typical asthma from week 8 to week 32
the ratio of progressing to typical asthma 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.
Measured: week 32
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.
Measured: 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.
Measured: baseline and week 8 ,baseline and week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough Variant AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xin Hua Hospital of Zhejiang Province, Hangzhou Hospital of Traditional Chinese Medicine, Affiliated Wenling Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Junchao Yang, Study chair, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459805
- Sponsor's protocol ID
- 2022ZZ011
- Other IDs
- ChiCTR2100048636
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ndividual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT05459805
- Acronym / sponsor ID
- 2022ZZ011
- Conditions
- Cough Variant Asthma
- Keywords
- cough variant asthma, traditional Chinese medicine, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Collaborators
- Xin Hua Hospital of Zhejiang Province, Hangzhou Hospital of Traditional Chinese Medicine, Affiliated Wenling Hospital of Wenzhou Medical University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: traditional chinese medicine Xuanfei-Zhike formula, Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)those receive ICS/LABA plus traditional Chinese medicine |
| group 2 | Active comparator | Drug: inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)those receive ICS/LABA alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- conform to diagnosis of CVA;
- 18 years≤age≤65 years;
- agree to participant in this trial.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional chinese medicine Xuanfei-Zhike formula200ml, bid, for 8 weeks | Drug | group 1 |
| inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA)one suction, q12h, for 8 weeks | Drug | group 1, group 2 |
Primary outcome
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 .
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 .
8 secondary outcomes
change from baseline in Cough-related Symptom Scale
Time frame: baseline and week 8 ,baseline and week 32
change from baseline in Cough severity visual analogue scale
Time frame: baseline and week 8 ,baseline and week 32
change from baseline in Leicester Cough Questionnaire
Time frame: baseline and week 8 ,baseline and week 32
change from baseline in Pulmonary function
Time frame: baseline and week 8 ,baseline and week 32
CVA recurrence rate from week 8 to week 32
Time frame: week 32
the ratio of progressing to typical asthma from week 8 to week 32
Time frame: week 32
change from baseline in fractional exhaled nitric oxide
Time frame: baseline and week 8 ,baseline and week 32
change from baseline in Serum IgE
Time frame: baseline and week 8 ,baseline and week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: Yes. ndividual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junchao Yang study chair
The First Affiliated Hospital of Zhejiang Chinese Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional chinese medicine Xuanfei-Zhike formula and inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) in people with Cough Variant Asthma, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junchao Yang (+86 13858036093, yangjunchaozj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total effective rate calculated by the Cough-related Symptom Scale (time frame: week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.