Back to resultsTreatment of Refractory Chronic Cough With PA101
Primary Purpose
Refractory Chronic Cough
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PA101
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Chronic Cough
Eligibility Criteria
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
Sites / Locations
- Erasmus Medical Center
- Isala
- Hull Clinical Trials Unit
- Uni Hospital Leicester
- King's College Hospital
- Royal Brompton & Harefield Hospital
- Uni Hospital North Staffordshire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PA101
Placebo
Arm Description
PA101, 40 mg administered via inhalation three times daily for 14 days
Placebo PA101, administered via inhalation three times daily for 14 days
Outcomes
Primary Outcome Measures
cough frequency
objective 24-hour cough monitoring
Secondary Outcome Measures
cough severity
VAS scale for cough severity
cough-related quality of life
Leicester Cough Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02412020
Brief Title
Treatment of Refractory Chronic Cough With PA101
Official Title
Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Patara Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PA101
Arm Type
Experimental
Arm Description
PA101, 40 mg administered via inhalation three times daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo PA101, administered via inhalation three times daily for 14 days
Intervention Type
Drug
Intervention Name(s)
PA101
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
cough frequency
Description
objective 24-hour cough monitoring
Time Frame
14 days
Secondary Outcome Measure Information:
Title
cough severity
Description
VAS scale for cough severity
Time Frame
14 days
Title
cough-related quality of life
Description
Leicester Cough Questionnaire
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Isala
City
Zwolle
Country
Netherlands
Facility Name
Hull Clinical Trials Unit
City
Cottingham
State/Province
East Yorkshire
Country
United Kingdom
Facility Name
Uni Hospital Leicester
City
Leicester
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Brompton & Harefield Hospital
City
London
Country
United Kingdom
Facility Name
Uni Hospital North Staffordshire
City
Stoke-on-Trent
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28923239
Citation
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.
Results Reference
derived
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Treatment of Refractory Chronic Cough With PA101
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