Refractory Chronic Cough Clinical Trial
Official title:
Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101
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.
The study consists of 2 treatment cohorts with refractory chronic cough: Idiopathic
Pulmonary Fibrosis (IPF, Cohort 1) and Chronic Idiopathic Cough (CIC, Cohort 2). In each
cohort, the study will include two treatment periods of 14 days each separated by a Washout
Period of 14 days between Period 1 and Period 2. The two periods will be identical except
that in Period 2, patients will crossover to the alternate treatment from that received in
Period 1, according to a 1:1 randomization scheme.
During each period, patients will self-administer study drug (i.e., 40 mg PA101 or Placebo
PA101 via eFlow) three times daily for 14 consecutive days of each period. Objective cough
count will be recorded over 24-hour period using a cough count device (Leicester Cough
Monitor) at the Baseline, Day 7 and Day 14 of each treatment period.
In the IPF cohort, patients will be allowed to use antifibrotic therapy (i.e., pirfenidone,
nintedanib, and N-acetylcysteine) during the course of the study provided that the dose is
stabilized at least 3 months prior to Screening and throughout the study period.
Clinical safety assessments will be performed at the start and end of each treatment period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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