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