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 - PA101-CC-01

Patara Pharma, LLC0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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

•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

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