A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is
 characterized by exertional dyspnea and persistent dry cough.

 Cough in IPF is both a presenting and a complicating clinical feature, which affects
 approximately three quarters of IPF cases. It is often a debilitating symptom that adversely
 affects quality of life (QoL) and is usually refractory to medical therapy.

 Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium
 delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b
 study for the treatment of persistent cough in patients with 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