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

NCT ID: NCT07272278

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Western Medicine Therapy Group

CVA patients receive ICS/LABA treatment

Group Type: ACTIVE_COMPARATOR

ICS+LABA

Intervention Type: DRUG

CVA patients receive ICS/LABA treatment

Integrated Chinese and Western Medicine Therapy Group

CVA patients receive ICS/LABA treatment and Chinese medicine treatment (Liqin Zhike Formula)

Group Type: EXPERIMENTAL

ICS+LABA

Intervention Type: DRUG

CVA patients receive ICS/LABA treatment

Chinese Medicine Formula

Intervention Type: DRUG

CVA patients receive ICS/LABA + Liqin Zhike Formula treatment

Interventions

ICS+LABA

CVA patients receive ICS/LABA treatment

Intervention Type: DRUG

Chinese Medicine Formula

CVA patients receive ICS/LABA + Liqin Zhike Formula treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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).

2. 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.

3. 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.

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Luanqing Che

Role: CONTACT

cheluanqing@163.com

15658869993

Other Identifiers

2025-1288

Identifier Type: -

Identifier Source: org_study_id