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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Persistent Cough in IPF, Chronic Cough, IPF

In brief

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.

Key facts

Study ID

NCT03864328

Run by

Respivant Sciences GmbH

People needed

108

Starts

2019-03-29

Expected to finish

2020-06-05

Last updated by the study team

2020-06-11

Who can join

Age: 40 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Davis — Sacramento, California, United States
• University California San Francisco — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• Ascension Medical Group / St. Vincent's Lung Institute — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Tampa General Hospital / Uni of South Florida — Tampa, Florida, United States
• Loyola University — Maywood, Illinois, United States
• Tulane University — New Orleans, Louisiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Universty of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• Cornell University Weill Cornell Medical College — New York, New York, United States
• American Health Research — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Pulmonix, LLC — Greensboro, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Spartanburg Medical Research — Spartanburg, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwester Medical Center — Dallas, Texas, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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