Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in patients with Idiopathic Pulmonary Fibrosis (IPF) with PA101.

Phase 2

Completed

Conditions: chronic cough
idiopathic pulmonary fibrosis
10062915
10046304
10024450

Registration Number: NL-OMON42283

Lead Sponsor: PATARA PHARMA LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

COHORT 1: IDIOPATHIC PULMONARY FIBROSIS (IPF, Cohort 1);1. Male or female patients age 40 through 79 years, inclusive
2. Diagnosis of Idiopathic Pulmonary Fibrosis with the consensus of the multidisciplinary team based on the presence of definitive or possible usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) and after excluding alternative diagnoses, including lung diseases associated with environmental and occupational exposure, with connective tissue diseases and with drugs
3. Chronic cough present for at least 8 weeks and not responsive to current therapies
4. Daytime cough severity score on visual analogue scale > 40 mm at the Screening Visit
5. Daytime average cough count of at least 15 coughs per hour using objective cough
count monitor at the Screening Visit
6. Transfer capacity for carbon monoxide corrected for hemoglobin (TLCOc) > 25%
predicted value within 12 months of the Screening Visit and Forced Vital Capacity (FVC) > 50% predicted value within 1 month of the Screening Visit
7. Willingness and ability to provide written informed consent;COHORT 2: CHRONIC IDIOPATHIC COUGH (CIC, Cohort 2);1. Male or female patients age 18 through 75 years, inclusive
2. Chronic cough that has been present for at least 8 weeks
3. Diagnosis of chronic idiopathic cough (CIC) that is unresponsive to targeted treatment for identified underlying triggers (i.e., post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease)
4. Cough score on visual analogue scale of > 40 mm at the Screening Visit
5. Daytime average cough count of at least 15 coughs per hour using objective cough
count monitor at the Screening Visit
6. Willingness and ability to provide written informed consent

Exclusion Criteria

COHORT 1: IDIOPATHIC PULMONARY FIBROSIS (IPF, Cohort 1);1. 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
2. Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month of the Screening Visit)
3. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
4. Acute exacerbation of IPF within 3 months of the Screening Visit
5. Long-term daily oxygen therapy (> 10 hours/day)
6. Presence of pulmonary arterial hypertension with limitation of activity
7. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ
8. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
9. Current or recent history (previous 12 months) of abusing legal drugs or use of illegal drugs or substances
10. Participation in any other investigational drug study within 4 weeks prior to the
Screening Visit
11. Use of the following drugs within 2 weeks of the Screening Visit: Prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium
12. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study (e.g., abstinence, combination barrier and spermicide, or hormonal)
13. History of hypersensitivity or intolerance to cromolyn sodium;COHORT 2: CHRONIC IDIOPATHIC COUGH (CIC, Cohort 2);1. 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
2. An upper or lower respiratory tract infection within 4 weeks of the Screening Visit
3. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ
4. Current or recent history (previous 12 months) of excessive use or abuse of alcohol
5. Current or recent history (previous 12 months) of abusing legal drugs or use of illegal drugs or substances
6. Participation in any other investigational drug study within 4 weeks prior to the Screening Visit
7. Use of the following drugs within 2 weeks of the Screening Visit: Prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium
8. Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study (e.g., abstinence, combination barrier and spermicide, or hormonal)
9. History of hypersensitivity or intolerance to cromolyn sodium

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effectiveness of inhaled PA101 delivered via eFlow® high<br /><br>efficiency nebulizer for treating chronic cough. Improvements in chronic cough<br /><br>will be assessed by measuring the change from baseline in the 24-hour objective<br /><br>cough count as measured by Leicester Cough Monitor (LCM).17 Other assessments<br /><br>will include changes in the quality of life score as measured by the Leicester<br /><br>Cough Questionnaire (LCQ)18 and King*s Brief Interstitial Lung Disease<br /><br>Questionnaire (K-BILD),19 changes in cough severity as measured by Visual<br /><br>Analog Scale (VAS),20 changes in pulmonary function tests (PFTs), and changes<br /><br>in fractional exhaled nitric oxide (FeNO) using Niox Vero®.</p><br>

Secondary Outcome Measures