AsthmaNCT07272278
Prospective Clinical Study on the Clinical Efficacy and Prognostic Outcome of ICS/LABA Combined With Liqin Zhike Formula in the Treatment of Cough Variant Asthma
A study testing ICS+LABA and Chinese Medicine Formula in people with Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
To investigate the impact of the combination of ICS/LABA and Liqin Zhike Formula on the clinical efficacy and prognostic outcomes of cough variant asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- ICS+LABA and Chinese Medicine Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject voluntarily participates in this study, complies with the study regulations, understands, agrees to, and cooperates with the required examinations, adheres to the follow-up plan, and voluntarily signs the written informed consent form.
- Outpatients, with age between 18 and 70 years old (inclusive).
- Newly diagnosed with Cough Variant Asthma (CVA) based on clinical symptoms and pulmonary function results, according to the Chinese Bronchial Asthma Prevention and Treatment Guidelines (2024 Edition) and the Guidelines for the Diagnosis and Treatment of Cough (2021 Edition). This involves chronic cough (lasting over 8 weeks) without accompanying wheezing symptoms or signs, often occurring at night and/or early morning and worsening after exercise. All patients must meet at least one of the following pulmonary function criteria, indicating variable airflow limitation, as objective evidence for asthma diagnosis:
- Objective Tests for Variable Airflow Limitation:
- Positive bronchodilator test: An increase in Forced Expiratory Volume in one second (FEV1) of ≥12% and an absolute increase in FEV1 of ≥200 ml after inhalation of a bronchodilator; OR an increase in FEV1 of ≥12% compared to baseline and an absolute increase of ≥200 ml after 4 weeks of anti-inflammatory treatment containing Inhaled Corticosteroids (ICS) (excluding respiratory infections).
- Positive bronchial provocation test: Commonly used inhaled agents are methacholine or histamine. A positive result is typically defined as a ≥20% decrease in FEV1 after inhalation of the provoking agent, indicating the presence of airway hyperresponsiveness. Bronchial provocation test can be performed when FEV1 is ≥70% of predicted value (excluding respiratory infections within 4 weeks). If FEV1 is <70% of predicted value, a bronchodilator test is prioritized.
- Average daily diurnal variation in Peak Expiratory Flow (PEF) >10% (calculated as the sum of daily PEF diurnal variation for at least 7 consecutive days divided by the total number of days), excluding respiratory infections.
- Cough severity score (CET) > 5 points. Patients previously diagnosed with CVA who discontinued inhaled medications for more than 3 months for any reason and now meet the above criteria.
Who cannot join
- Inability to cooperate with the diagnostic tests for asthma or uncooperative for other reasons.
- Pregnancy. Comorbid severe diseases of other systems (e.g., cardiovascular, metabolic, immune, nervous, urinary, hematological) that may interfere with the normal conduct of this study.
- A clear history of upper respiratory tract infection within the 4 weeks prior to enrollment.
- History of alcohol abuse or substance abuse, or history of psychiatric illness, antagonistic personality, ulterior motives, paranoia, or other emotional or intellectual problems that may compromise the validity of informed consent or participation in the study.
- Chest imaging indicates clinically significant abnormalities related to the symptoms.
- Smoking: Defined as having smoked more than 100 cigarettes in one's lifetime and having smoked within the past 5 years. Otherwise, considered a non-smoker.
- Current use of ACEI (Angiotensin-Converting Enzyme Inhibitor) medications. Concurrent participation in another drug clinical trial, or deemed unsuitable for inclusion in this study by the investigator for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To investigate the impact of the combination of ICS/LABA and Liqin Zhike Formula on the clinical efficacy and prognostic outcomes of cough variant asthma.
Read the detailed description
A total of 236 patients with cough variant asthma were enrolled and randomly assigned in a 1:1 ratio. Among them, 118 patients were allocated to the Western medicine treatment group and received ICS/LABA + conventional therapy, while the other 118 patients were assigned to the integrated Chinese and Western medicine treatment group and received ICS/LABA + Liqin Zhike Formula. The treatment intervention period for both groups was 2 months, followed by a 12-month drug-discontinuation follow-up. During the 12-month follow-up period, symptom recurrence rate, asthma symptom remission rate, and adverse reactions were observed. The primary study endpoint was the symptom recurrence rate in patients with cough variant asthma during the 12-month follow-up. The secondary study endpoints were the asthma symptom remission rate and adverse reactions.
- Conditions
- Asthma
- Being tested
- ICS+LABA, Chinese Medicine Formula
- Keywords
- symptom recurrence rate, cough, ICS/LABA, Traditional Chinese Medicine (TCM) treatment, Liqin Zhike Formula
- Medical subject headings
- Asthma, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICS+LABADrug
CVA patients receive ICS/LABA treatment
Chinese Medicine FormulaDrug
CVA patients receive ICS/LABA + Liqin Zhike Formula treatment
| Study group | Role | What they receive |
|---|---|---|
| Western Medicine Therapy Group | Active comparator | CVA patients receive ICS/LABA treatment Receives: Drug: ICS+LABA |
| Integrated Chinese and Western Medicine Therapy Group | Experimental | CVA patients receive ICS/LABA treatment and Chinese medicine treatment (Liqin Zhike Formula) Receives: Drug: ICS+LABA; Drug: Chinese Medicine Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom recurrence rate
symptom recurrence rate in patients with cough variant asthma
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272278
- Sponsor's protocol ID
- 2025-1288
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on the Clinical Efficacy and Prognostic Outcome of ICS/LABA Combined With Liqin Zhike Formula in the Treatment of Cough Variant Asthma
- ClinicalTrials.gov ID
- NCT07272278
- Acronym / sponsor ID
- 2025-1288
- Conditions
- Asthma
- Keywords
- symptom recurrence rate, cough, ICS/LABA, Traditional Chinese Medicine (TCM) treatment, Liqin Zhike Formula
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (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 investigate the impact of the combination of ICS/LABA and Liqin Zhike Formula on the clinical efficacy and prognostic outcomes of cough variant asthma.
Detailed description
A total of 236 patients with cough variant asthma were enrolled and randomly assigned in a 1:1 ratio. Among them, 118 patients were allocated to the Western medicine treatment group and received ICS/LABA + conventional therapy, while the other 118 patients were assigned to the integrated Chinese and Western medicine treatment group and received ICS/LABA + Liqin Zhike Formula. The treatment intervention period for both groups was 2 months, followed by a 12-month drug-discontinuation follow-up. During the 12-month follow-up period, symptom recurrence rate, asthma symptom remission rate, and adverse reactions were observed. The primary study endpoint was the symptom recurrence rate in patients with cough variant asthma during the 12-month follow-up. The secondary study endpoints were the asthma symptom remission rate and adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Western Medicine Therapy Group | Active comparator | Drug: ICS+LABACVA patients receive ICS/LABA treatment |
| Integrated Chinese and Western Medicine Therapy Group | Experimental | Drug: ICS+LABA, Drug: Chinese Medicine FormulaCVA patients receive ICS/LABA treatment and Chinese medicine treatment (Liqin Zhike Formula) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject voluntarily participates in this study, complies with the study regulations, understands, agrees to, and cooperates with the required examinations, adheres to the follow-up plan, and voluntarily signs the written informed consent form.
- Outpatients, with age between 18 and 70 years old (inclusive).
- Newly diagnosed with Cough Variant Asthma (CVA) based on clinical symptoms and pulmonary function results, according to the Chinese Bronchial Asthma Prevention and Treatment Guidelines (2024 Edition) and the Guidelines for the Diagnosis and Treatment of Cough (2021 Edition). This involves chronic cough (lasting over 8 weeks) without accompanying wheezing symptoms or signs, often occurring at night and/or early morning and worsening after exercise. All patients must meet at least one of the following pulmonary function criteria, indicating variable airflow limitation, as objective evidence for asthma diagnosis:
- Positive bronchodilator test: An increase in Forced Expiratory Volume in one second (FEV1) of ≥12% and an absolute increase in FEV1 of ≥200 ml after inhalation of a bronchodilator; OR an increase in FEV1 of ≥12% compared to baseline and an absolute increase of ≥200 ml after 4 weeks of anti-inflammatory treatment containing Inhaled Corticosteroids (ICS) (excluding respiratory infections).
- Positive bronchial provocation test: Commonly used inhaled agents are methacholine or histamine. A positive result is typically defined as a ≥20% decrease in FEV1 after inhalation of the provoking agent, indicating the presence of airway hyperresponsiveness. Bronchial provocation test can be performed when FEV1 is ≥70% of predicted value (excluding respiratory infections within 4 weeks). If FEV1 is <70% of predicted value, a bronchodilator test is prioritized.
Key exclusion criteria (7 listed)
- Inability to cooperate with the diagnostic tests for asthma or uncooperative for other reasons.
- Pregnancy. Comorbid severe diseases of other systems (e.g., cardiovascular, metabolic, immune, nervous, urinary, hematological) that may interfere with the normal conduct of this study.
- A clear history of upper respiratory tract infection within the 4 weeks prior to enrollment.
- History of alcohol abuse or substance abuse, or history of psychiatric illness, antagonistic personality, ulterior motives, paranoia, or other emotional or intellectual problems that may compromise the validity of informed consent or participation in the study.
- Chest imaging indicates clinically significant abnormalities related to the symptoms.
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 |
|---|---|---|
| ICS+LABACVA patients receive ICS/LABA treatment | Drug | Integrated Chinese and Western Medicine Therapy Group, Western Medicine Therapy Group |
| Chinese Medicine FormulaCVA patients receive ICS/LABA + Liqin Zhike Formula treatment | Drug | Integrated Chinese and Western Medicine Therapy Group |
Primary outcome
symptom recurrence rate
Time frame: 12 month follow up
symptom recurrence rate in patients with cough variant asthma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ICS+LABA and Chinese Medicine Formula in people with Asthma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luanqing Che (15658869993, cheluanqing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom recurrence rate (time frame: 12 month follow up). 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 9 Dec 2025.