Treatment of Refractory Chronic Cough With PA101
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02412020|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : February 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory Chronic Cough||Drug: PA101 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||February 2016|
PA101, 40 mg administered via inhalation three times daily for 14 days
Placebo Comparator: Placebo
Placebo PA101, administered via inhalation three times daily for 14 days
- cough frequency [ Time Frame: 14 days ]objective 24-hour cough monitoring
- cough severity [ Time Frame: 14 days ]VAS scale for cough severity
- cough-related quality of life [ Time Frame: 14 days ]Leicester Cough Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02412020
|Erasmus Medical Center|
|Hull Clinical Trials Unit|
|Cottingham, East Yorkshire, United Kingdom|
|Uni Hospital Leicester|
|Leicester, United Kingdom|
|King's College Hospital|
|London, United Kingdom|
|Royal Brompton & Harefield Hospital|
|London, United Kingdom|
|Uni Hospital North Staffordshire|
|Stoke-on-Trent, United Kingdom|