Working… Menu

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. Identifier: NCT02412020
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : February 22, 2016
Information provided by (Responsible Party):
Patara Pharma

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
cough frequency [ Time Frame: 14 days ]
objective 24-hour cough monitoring
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
cough frequency [ Time Frame: 14 days ]
objective 24 hour cough count
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • cough severity [ Time Frame: 14 days ]
    VAS scale for cough severity
  • cough-related quality of life [ Time Frame: 14 days ]
    Leicester Cough Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Treatment of Refractory Chronic Cough With PA101
Official Title  ICMJE Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101
Brief 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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Refractory Chronic Cough
Intervention  ICMJE
  • Drug: PA101
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: PA101
    PA101, 40 mg administered via inhalation three times daily for 14 days
    • Drug: PA101
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo PA101, administered via inhalation three times daily for 14 days
    • Drug: PA101
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2015)
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of Idiopathic Pulmonary Fibrosis (based on presence of definitive or possible usual interstitial pneumonia UIP pattern on high-resolution computed tomography and after excluding lung diseases associated with environmental and occupational exposure, with connective tissue disease and with drugs; transfer capacity for carbon monoxide corrected for hemoglobin [TLCOc] >25% predicted within 12 months of Screening; and forced vital capacity [FRC] >50% predicted within 1 month of Screening) or Chronic Idiopathic Cough (that is unresponsive to targeted treatment for identified underlying triggers including post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease)
  • Refractory chronic cough for at least 8 weeks
  • Daytime cough severity score >40 mm on Cough Severity VAS at Screening
  • Daytime average cough count ≥15 per hour at Screening
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Current or recent history of clinically significant medical condition, laboratory abnormality or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
  • Upper or lower respiratory tract infection within 4 weeks of Screening
  • History of malignancy treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ
  • Current or recent history (within 12 months) of excessive use or abuse of alcohol
  • Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances
  • Participation in any other investigational drug study within 4 weeks of Screening
  • Use of prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium within 2 weeks of Screening
  • Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02412020
Other Study ID Numbers  ICMJE PA101-CC-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patara Pharma
Study Sponsor  ICMJE Patara Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Patara Pharma
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP