A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
NCT ID: NCT03864328
Last Updated: 2020-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
108 participants
INTERVENTIONAL
2019-03-29
2020-06-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RVT-1601 Low Dose
RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer
RVT-1601 Mid Dose
RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer
RVT-1601 High Dose
RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer
Placebo
Placebo
Inhaled Placebo administered TID via eFlow nebulizer
Interventions
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RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer
Placebo
Inhaled Placebo administered TID via eFlow nebulizer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
89 Years
ALL
No
Sponsors
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Respivant Sciences Inc.
INDUSTRY
Respivant Sciences GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmet Tutuncu, MD, PhD
Role: STUDY_DIRECTOR
Respivant Sciences Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
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 Utah Hospitals & Clinics
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington School of Medicine
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Lung Research Quensland
Chermside, Quensland, Australia
Mater Research
South Brisbane, Quensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Frankston Hospital-Peninsula Health
Frankston, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Alfred Health
Westmead, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Trialswest
Perth, Western Australia, Australia
University Clinic Saint-Luc
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Dalhousie University
Halifax, , Canada
McMaster University
Hamilton, , Canada
Centre Hospitalier Universitaire de Montreal
Montreal, , Canada
University Health Network, Toronto General Hospital
Toronto, , Canada
St. Paul's Hospital
Vancouver, , Canada
Thomayer Hospital
Prague, , Czechia
Evangelische Lungerklinik Berlin
Berlin, , Germany
University Clinic Bonn
Bonn, , Germany
Ruhrlandklinik-Universitätsmedizin Essen
Essen, , Germany
Pneumologische Klinik Waldhof Elgerhausen
Greifenstein, , Germany
Medizinische Hochshule Hannover
Hanover, , Germany
University Heidelberg
Heidelberg, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Krankenhaus Bethanian
Solingen, , Germany
Bologna University Hospital
Bologna, , Italy
University of Catania
Catania, , Italy
A.O.U. Policlinico di Modena
Modena, , Italy
University of Padova
Padua, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Siena University Hospital
Siena, , Italy
University of Torino
Torino, , Italy
VU Medical Center
Amsterdam, , Netherlands
Zuyderland Medical Center
Heerlen, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haaglanden Medical Center
The Hague, , Netherlands
Greenlane Clinical Center
Auckland, , New Zealand
University of Otago
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Cukurova University
Adana, , Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, , Turkey (Türkiye)
Ege University Hospital
Izmir, , Turkey (Türkiye)
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
University of Edinburgh
Edinburgh, , United Kingdom
University of Leicester
Leicester, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
University of Manchester
Manchester, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
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Other Identifiers
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RVT1601-CC-04
Identifier Type: -
Identifier Source: org_study_id
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