Randomized, Double-blind, Placebo-controlled, Three-Period Crossover Study to Assess the Safety and Tolerability of Inhaled PA101 in Idiopathic Pulmonary Fibrosis (IPF) Patients with Chronic Cough

Completed

• Conditions: Idiopathic Pulmonary fibrosis; Scarring of lung tissue with unknown cause; 10006436

• Registration Number: NL-OMON41901
• Lead Sponsor: Patara Pharma, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

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. Transfer capacity for carbon monoxide corrected for hemoglobin (TLCOc) >25% predicted value within 3 months and Forced Vital Capacity (FVC) >50% predicted value within 1 month of the Screening Visit

Exclusion Criteria

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 cardiac 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;11. Use of the following drugs within 2 weeks prior to the Screening Visit: Prednisone, narcotic antitussives, baclofen, gabapentin, and inhaled corticosteroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The efficacy variables for this study will be:<br /><br>* Change from pre-dose Day 1 to pre-dose Day 4 in 24-hour cough severity<br /><br>measured by VAS scale<br /><br>* Change from pre-dose Day 1 to pre-dose Day 4 in urge-to-cough measured by VAS<br /><br>scale<br /><br>* Change in total cough count measured by LCM from the first 24 hours of<br /><br>monitoring to the last 24 hours of monitoring<br /><br><br /><br>Safety outcome variables for this study will include AEs and changes from<br /><br>baseline in the following parameters:<br /><br>* Change from pre- to post-dose in vital signs (i.e., systolic/diastolic blood<br /><br>pressure, heart rate) on Days 1 and 4<br /><br>* Change from pre- to post-dose in 12-lead ECG parameters (including QTc) on<br /><br>Days 1 and 4<br /><br>* Change in PFTs (i.e., FEV1, FVC and FEV1/FVC ratio) from pre-dose on Day 1 to<br /><br>post-dose on Day 4</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>