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

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.