PT  - JOURNAL ARTICLE
AU  - Surinder Birring
AU  - Marlies Wijsenbeek
AU  - Sanjay Agrawal
AU  - Ahmet Tutuncu
AU  - Alyn Morice
TI  - LATE-BREAKING ABSTRACT: Significant improvement in refractory chronic cough with inhaled PA101 in patients with idiopathic pulmonary fibrosis: Results from phase 2 trial
AID  - 10.1183/13993003.congress-2016.OA4958
DP  - 2016 Sep 01
TA  - European Respiratory Journal
PG  - OA4958
VI  - 48
IP  - suppl 60
4099  - http://erj.ersjournals.com/content/48/suppl_60/OA4958.short
4100  - http://erj.ersjournals.com/content/48/suppl_60/OA4958.full
SO  - Eur Respir J2016 Sep 01; 48
AB  - Introduction Cough can be a debilitating symptom of idiopathic pulmonary fibrosis (IPF) and is difficult to treat. PA101 is a novel formulation of cromolyn sodium delivered via a high-efficiency nebuliser (PARI eFlow®) that achieves significantly higher lung deposition compared to previous formulations. We investigated the efficacy and safety of inhaled PA101 on chronic cough in IPF patients in a randomised, double-blind, placebo controlled, 2-period cross-over trial.Methods 24 IPF patients with refractory cough (mean age 67yr, male 63%, mean FVC 73% and median cough duration 4.0yr) were randomized to receive PA101 (40mg tid) or matching placebo for 2 weeks, followed by 2 weeks wash out, and then crossed over. Objective 24hr cough frequency (Leicester Cough Monitor) and subjective cough-specific QoL (Leicester Cough Questionnaire, LCQ) were assessed at Day 14. Analysis: ITT/Mixed Effects Model.Results There was a significant 31% reduction in daytime cough frequency at Day 14 vs baseline with PA101 when adjusted for placebo (p=0.02). LCQ scores improved with PA101 compared to placebo (mean diff 1.1, p=0.09). PA101 was well tolerated, adverse events were comparable to placebo, and there were no serious AEs.Conclusions Inhaled PA101 appears to be a promising treatment option for refractory cough in IPF and warrants further investigation.Daytime average cough frequency.