Efficacy and safety of gabapentin for treatment of cough in idiopathic pulmonary fibrosis: a randomized, double-blinded, placebo-controlled clinical trial.

Authors

Yaxing Zhou, Xu Ju, Yuan Zhang, Shengyuan Wang, Tongyangzi Zhang, Ronglin Gao, Ya Li, Xuan Wang, Li Yu, Xianghuai Xu

Published in

Chest. Aug 29, 2026. Epub Aug 29, 2026.

Abstract

Cough is common in idiopathic pulmonary fibrosis (IPF) and substantially impairs quality of life, but effective treatment options are limited. Gabapentin reduces cough in refractory chronic cough, but its efficacy and safety in IPF-related cough are uncertain.
Does gabapentin improve cough in patients with IPF?
This study was a randomized, double-blind, placebo-controlled clinical trial conducted at Tongji Hospital, Tongji University. Patients diagnosed with IPF according to the ATS/ERS/JRS/ALAT guidelines, with chronic cough lasting for more than 8 weeks and a cough visual analog scale (VAS) score ≥40 mm, were included. Participants were randomly assigned in a 1:1 ratio to receive either gabapentin or placebo. Gabapentin was titrated to a maximum of 900 mg/d during 12 weeks of treatment, followed by a 4-week post-treatment follow-up. The primary endpoint was the cough relief rate at T4 (end of treatment), defined as the proportion of participants achieving a reduction of at least 50% in total Cough Symptom Score (CSS) from baseline. Safety was assessed in all participants who received at least one dose of study treatment.
Between May 1, 2021, and December 31, 2024, 72 participants were screened, of whom 68 were randomized to gabapentin or placebo. Five participants withdrew prior to study completion. At T4, the cough relief rate was higher with gabapentin than with placebo (73.5% vs 26.5%), with a placebo-adjusted absolute difference of 47.1 percentage points (95% CI, 26.1-68.0; P < 0.001). During treatment, adverse events occurred in 32.4% of participants receiving gabapentin and 8.8% receiving placebo. The most common adverse events in the gabapentin group were drowsiness, fatigue, and dizziness.
Gabapentin demonstrated significant efficacy with an acceptable safety profile in treating cough in IPF. These findings support gabapentin as a potential treatment option for IPF-related cough.
The study was registered with the Chinese Clinical Trial Registry (ChiCTR2100045202).

PMID:
42668062
Bibliographic data and abstract were imported from PubMed on 30 Aug 2026.

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