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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
Information provided by (Responsible Party):
Patara Pharma

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.

Condition or disease Intervention/treatment Phase
Refractory Chronic Cough Drug: PA101 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. cough frequency [ Time Frame: 14 days ]
    objective 24-hour cough monitoring

Secondary Outcome Measures :
  1. cough severity [ Time Frame: 14 days ]
    VAS scale for cough severity

  2. cough-related quality of life [ Time Frame: 14 days ]
    Leicester Cough Questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

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Erasmus Medical Center
Rotterdam, Netherlands
Zwolle, Netherlands
United Kingdom
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
Sponsors and Collaborators
Patara Pharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patara Pharma
ClinicalTrials.gov Identifier: NCT02412020    
Other Study ID Numbers: PA101-CC-02
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory