AsthmaNCT06199830
A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough
An observational study of Asthma, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- positive bronchial provocation test
- Type of treatment
- Injection or infusion
- How many people
- 645 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Aug 2023
- Phase
- Observational
- 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
Study population: We retrospectively collected information from patients with CC who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019.
Who may be able to join
- (1) age from 18 years old to 65 years old; (2) clinical diagnosis of CVA and CC .
Who cannot join
- Exclusion criteria for CVA were: a history of COPD, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (UACS) and gastroesophageal reflux-related cough (GERC) or other apparent causes of cough; patients who used corticosteroid (ICS) in the previous four weeks; Exclusion criteria for CC were: a history of variable airway limitation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou
About this study
this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.
Read the detailed description
the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019. Data of external test were also from the First Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January 2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by professional technicians. Characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.
- Conditions
- Asthma
- Being tested
- positive bronchial provocation test
- Keywords
- small airway dysfunction, cough variant asthma, Chronic cough
- Medical subject headings
- Asthma, Cough-Variant Asthma, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive bronchial provocation testDiagnostic test
Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%.
| Study group | Role | What they receive |
|---|---|---|
| cough variant asthma | (1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) variable airway limitation evaluated by BHR test; (3) a positive response to anti-asthma therapy; (4) No other causes of chronic cough. Receives: Diagnostic Test: positive bronchial provocation test | |
| chronic cough | (1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) without radiographic evidence of lung disease; (3) with no fever, blood-stained sputum or other active respiratory injection; |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive bronchial provocation test
Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%
Measured: up to 1 week
Secondary outcomes (1)
small airway dysfuction
MMEF% pred, FEF50% pred, FEF75% pred
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Mar 2022
- Primary completion20 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junchao Yang, Dr, Principal investigator, The First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199830
- Sponsor's protocol ID
- 2023-KLS-100-01
- Status last verified
- Dec 2023
- First submitted
- 20 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ni K, Wang S, Zhang X, Liu S, Zhang Y, Li Y, Wang Y, Yang J. Association between clinical and pulmonary function features and diagnosis of cough variant asthma: a case-control study. BMJ Open. 2025 Feb 22;15(2):e084721. doi: 10.1136/bmjopen-2024-084721.
PubMed 39987008
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough
- ClinicalTrials.gov ID
- NCT06199830
- Acronym / sponsor ID
- 2023-KLS-100-01
- Conditions
- Asthma
- Keywords
- small airway dysfunction, cough variant asthma, Chronic cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 10 Jan 2024 (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.
this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.
Detailed description
the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019. Data of external test were also from the First Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January 2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by professional technicians. Characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cough variant asthma | – | Diagnostic Test: positive bronchial provocation test(1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) variable airway limitation evaluated by BHR test; (3) a positive response to anti-asthma therapy; (4) No other causes of chronic cough. |
| chronic cough | – | –(1) chronic cough (≥8 weeks) as the sore or predominant symptom; (2) without radiographic evidence of lung disease; (3) with no fever, blood-stained sputum or other active respiratory injection; |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively collected information from patients with CC who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019.
Key inclusion criteria (1 listed)
- (1) age from 18 years old to 65 years old; (2) clinical diagnosis of CVA and CC .
Key exclusion criteria (1 listed)
- Exclusion criteria for CVA were: a history of COPD, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (UACS) and gastroesophageal reflux-related cough (GERC) or other apparent causes of cough; patients who used corticosteroid (ICS) in the previous four weeks; Exclusion criteria for CC were: a history of variable airway limitation.
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 |
|---|---|---|
| positive bronchial provocation testPatients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%. | Diagnostic test | cough variant asthma |
Primary outcome
positive bronchial provocation test
Time frame: up to 1 week
Patients were asked to inhale gradually increasing doses of methacholine (0.9% saline, 0.078, 0.312, 1.125 and 2.504 mg), and FEV1 was measured after each inhalation. This test was stopped until a reducing in baseline FEV1 of 20%
1 secondary outcome
small airway dysfuction
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39987008Ni K, Wang S, Zhang X, Liu S, Zhang Y, Li Y, Wang Y, Yang J. Association between clinical and pulmonary function features and diagnosis of cough variant asthma: a case-control study. BMJ Open. 2025 Feb 22;15(2):e084721. doi: 10.1136/bmjopen-2024-084721.
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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, Dr principal investigator
The First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive bronchial provocation test (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199830, which also lists 1 linked publication.
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 15 Oct 2024.