Treatment of Refractory Chronic Cough With PA101

Summary

This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in adult patients with refractory chronic cough. The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating refractory chronic cough.

Timeline

Start

2015-02

Primary completion

2016-01

Completion

2016-02

Outcome

Mixed primary results

paper PA101 reduced daytime cough frequency by 31·1% at day 14 compared with placebo PMID 28923239 ↗

paper ratio of least-squares [LS] means 0·67, 95% CI 0·48-0·94, p=0·0241 PMID 28923239 ↗

paper no treatment benefit for PA101 was observed in the CIC cohort PMID 28923239 ↗

paper mean reduction of daytime cough frequency at day 14 for PA101 adjusted for placebo was 6·2% (ratio of LS means 1·27, 0·78-2·06, p=0·31) PMID 28923239 ↗

Publications

• Birring SS, Wijsenbeek MS, Agrawal S, van den Berg JWK, Stone H, Maher TM, Tutuncu A, Morice AH. A novel formulation of inhaled sodium cromoglicate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomised, double-blind, proof-of-concept, phase 2 trial. Lancet Respir Med. 2017 Oct;5(10):806-815. doi: 10.1016/S2213-2600(17)30310-7. Epub 2017 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cromolyn	Small molecule	40 mg	Inhaled

Indications