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February 26, 2026Open Access

Clinical Efficacy of Acupuncture as Adjunctive Therapy for Cough Variant Asthma: Study Protocol for a Pilot Randomized Controlled Trial

XCXi ChenChengdu University of Traditional Chinese Medicine YLYilin LiuChengdu University of Traditional Chinese Medicine HLHangYu LiChengdu University of Traditional Chinese Medicine

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This pilot trial aims to assess the feasibility and preliminary efficacy of acupuncture for cough variant asthma.
Multicenter, randomized, sham-controlled trial design
Participants randomized to receive real acupuncture or sham acupuncture alongside standard inhaled corticosteroid care
16 sessions of acupuncture over 8 weeks with an additional 8-week follow-up
Outcomes measured include cough severity, psychological assessments, and objective biomarkers
Primary outcome assessed is a ≥50% reduction in cough severity after 8 weeks
Secondary outcomes include changes in patient-reported cough severity and psychological measures
Biomarkers such as fractional exhaled nitric oxide and eosinophil counts will be evaluated

Resumen

Background: Cough variant asthma (CVA) is a clinically significant asthma phenotype and a major cause of chronic cough, with a substantial risk of progressing to classic asthma. Acupuncture has shown potential in alleviating cough, modulating airway inflammation, and improving quality of life, though high-quality evidence in CVA remains limited. This multicenter pilot trial aims to evaluate the feasibility and preliminary efficacy of acupuncture as adjunctive therapy for CVA. Methods and Analysis: This multicenter, randomized, sham-controlled pilot trial is designed to assess the feasibility, safety, and preliminary efficacy of acupuncture as adjunctive therapy for CVA. Eighty-eight participants will be randomized 1:1 to receive real acupuncture (RA) or sham acupuncture (SA), in addition to inhaled corticosteroid (ICS)-based standard care. The intervention comprises 16 sessions over 8 weeks, with an additional 8-week follow-up. The primary outcome is the effective response rate at week 8, defined as a ≥ 50% reduction in cough severity on the visual analogue scale (VAS). Secondary outcomes include patient-reported measures such as the Cough Severity Diary (CSD), Cough Hypersensitivity Questionnaire (CHQ), Cough Evaluation Test (CET), and Leicester Cough Questionnaire (LCQ); psychological and sleep assessments using the Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Pittsburgh Sleep Quality Index (PSQI); and objective biomarkers including fractional exhaled nitric oxide (FeNO) and peripheral blood eosinophil counts. Ethics and Dissemination: Ethical approval was obtained from the Medical Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (No. 2024KL-208). The results of this study will be distributed through peer-reviewed journals. Clinical Trial Registration: https://itmctr.ccebtcm.org.cn , identifier ITMCTR2025000435. Registered on 27 February 2025. Keywords: cough variant asthma, acupuncture, randomized controlled trial, study protocol

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