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

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