Treatment of Refractory Chronic Cough With PA101

• Register: ClinicalTrials.gov
• Last refreshed on: 14 March 2016
• Main ID: NCT02412020
• Date of registration: 03/04/2015
• Prospective Registration: No
• Primary sponsor: Patara Pharma
• Public title: Treatment of Refractory Chronic Cough With PA101
• Scientific title: Treatment of Chronic Idiopathic Cough and Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis With PA101
• Date of first enrolment: February 2015
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02412020
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Netherlands, United Kingdom

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Refractory Chronic Cough

Intervention(s)

Drug: Placebo

Drug: PA101

Primary Outcome(s)

cough frequency [Time Frame: 14 days]

Secondary Outcome(s)

cough-related quality of life [Time Frame: 14 days]

cough severity [Time Frame: 14 days]

Secondary ID(s)

PA101-CC-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors