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Treatment of Refractory Chronic Cough With PA101

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

April 3, 2015
April 8, 2015
February 22, 2016
February 2015
January 2016   (Final data collection date for primary outcome measure)
cough frequency [ Time Frame: 14 days ]
objective 24-hour cough monitoring
cough frequency [ Time Frame: 14 days ]
objective 24 hour cough count
Complete list of historical versions of study NCT02412020 on ClinicalTrials.gov Archive Site
  • cough severity [ Time Frame: 14 days ]
    VAS scale for cough severity
  • cough-related quality of life [ Time Frame: 14 days ]
    Leicester Cough Questionnaire
Same as current
Not Provided
Not Provided
 
Treatment of Refractory Chronic Cough With PA101
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Refractory Chronic Cough
  • Drug: PA101
  • Drug: Placebo
  • Experimental: PA101
    PA101, 40 mg administered via inhalation three times daily for 14 days
    Interventions:
    • Drug: PA101
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo PA101, administered via inhalation three times daily for 14 days
    Interventions:
    • Drug: PA101
    • Drug: Placebo
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
48
February 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
 
NCT02412020
PA101-CC-02
No
Not Provided
Not Provided
Patara Pharma
Patara Pharma
Not Provided
Not Provided
Patara Pharma
February 2016

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