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

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial

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