An interventional study of ICS+LABA and Chinese Medicine Formula in Asthma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 236 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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 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:
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.
Exclusion Criteria:
- 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 or participation in the study.
Chest imaging indicates 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CVA patients receive ICS/LABA treatment
Drug: ICS+LABA
CVA patients receive ICS/LABA treatment and Chinese medicine treatment (Liqin Zhike Formula)
Drug: ICS+LABA · Drug: Chinese Medicine Formula
CVA patients receive ICS/LABA treatment
CVA patients receive ICS/LABA + Liqin Zhike Formula treatment
symptom recurrence rate
symptom recurrence rate in patients with cough variant asthma
Time frame: 12 month follow up
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →