A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF

Inclusion Criteria: * Male or female subjects age 40 through 89 years * Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines * Persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to anti-tussive therapy * Daytime cough severity score of ≥ 40 mm on a 100-mm VAS * 24-hour average cough count of at least 10 coughs per hour * Forced Vital Capacity (FVC) \> 45% predicted value within 4 weeks * Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) \> 30% predicted value within 4 weeks * Life expectancy of at least 12 months Exclusion Criteria: * Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data * Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month) * Upper or lower respiratory tract infection within 4 weeks * Acute exacerbation of IPF within 6 months * Lung transplantation expected within 12 months * Requiring supplemental O2 \> 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) \> 88% at rest * History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years * Current smoker (i.e., use of tobacco products within the last 3 months) * Current or recent history of drug or alcohol abuse within 12 months * Participation in any other investigational drug study within 4 weeks * Use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators * Use of ACE inhibitors or cromolyn sodium within 4 weeks * Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study * History of hypersensitivity or intolerance to cromolyn sodium