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

• Status: Terminated
• Trial end date: 2020-06-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Respivant Sciences GmbH
• Collaborator: Respivant Sciences Inc.

Criteria

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