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Open Access 01-12-2022 | Cough | Study protocol

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

Authors: Ronglin Gao, Xianghuai Xu, Shengyuan Wang, Jincheng Pu, Cuiqin Shi, Siwan Wen, Yiqing Zhu, Jianping Tang, Xuan Wang, Li Yu

Published in: Trials | Issue 1/2022

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

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Title: 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
Authors: Ronglin Gao
Xianghuai Xu
Shengyuan Wang
Jincheng Pu
Cuiqin Shi
Siwan Wen
Yiqing Zhu
Jianping Tang
Xuan Wang
Li Yu
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Cough
Gastroesophageal Reflux Disease
Cough
Cough
Gabapentin
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06059-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods/design

Discussion

Trial registration

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