The efficacy of gabapentin for the treatment of refractory cough associated with interstitial lung disease: study protocol for a randomized, double-blind and placebo-controlled clinical trial

Abstract

Introduction: Gabapentin, a neurotransmitter modulator, is thought to treat refractory cough associated with interstitial lung disease by improving cough hypersensitivity. Methods/design: This is a single-center, prospective, randomized, double-blind, placebo-controlled trial. The trial will investigate the effect of a 10-week course of oral gabapentin 900 mg/day on refractory cough associated with interstitial lung disease (ILD) and explore the possible mechanisms involved in improving cough symptoms. A total of 84 individuals will be randomized in a 1:1 ratio to two treatment groups and will be followed for a total of 14 weeks from the first dose. The primary endpoint of the study will be the change in cough symptom scores at 14 weeks. The secondary endpoints include the change in Leicester Quality of Life Questionnaire (LCQ), Gastroesophageal Reflux Disease Questionnaire (Gerd Q), and Hull Airway Reflux Questionnaire (HARQ) scores; cough sensitivity (C2 and C5) values; and safety. Discussion: This study will be the first randomized, controlled clinical trial to investigate gabapentin for the treatment of refractory cough associated with interstitial lung disease and provide data on efficacy, safety, and quality of life. If the study confirms that gabapentin is effective in improving refractory cough associated with interstitial lung disease, it will indicate that a deeper understanding of its mechanisms may reveal new therapeutic targets. Trial registration: Chinese Clinical Trial Registry ChiCTR2100045202. Registered on 8 April 2021, www.chictr.org.cn