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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 89 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03864328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Respivant Sciences GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ahmet Tutuncu, MD, PhD
Principal Investigator Affiliation Respivant Sciences Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Czechia, Germany, Italy, Netherlands, New Zealand, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Persistent Cough in IPF, Chronic Cough, IPF

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Seattle, Washington

Status

Not yet recruiting

Address

University of Washington School of Medicine

Seattle, Washington, 98195

Site Contact

Lawrence Ho, MD

atutuncu@respivant.com

858-436-1627

University of Virginia, Charlottesville, Virginia

Status

Not yet recruiting

Address

University of Virginia

Charlottesville, Virginia, 22903

Site Contact

Hannah Mannem, MD

atutuncu@respivant.com

858-436-1627

University of Utah Hospitals & Clinics, Salt Lake City, Utah

Status

Not yet recruiting

Address

University of Utah Hospitals & Clinics

Salt Lake City, Utah, 84103

Site Contact

Mary Beth Scholand, MD

atutuncu@respivant.com

858-436-1627

UT Southwester Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwester Medical Center

Dallas, Texas, 75390

Site Contact

Craig Glazer, MD

atutuncu@respivant.com

858-436-1627

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Site Contact

Lisa Lancaster, MD

atutuncu@respivant.com

858-436-1627

Spartanburg Medical Research, Spartanburg, South Carolina

Status

Recruiting

Address

Spartanburg Medical Research

Spartanburg, South Carolina, 29303

Site Contact

Charles Fogarty, MD

atutuncu@respivant.com

864-583-1556

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Timothy Whelan, MD

atutuncu@respivant.com

858-436-1627

Temple University School of Medicine, Philadelphia, Pennsylvania

Status

Recruiting

Address

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140

Site Contact

Gerard Criner, MD

atutuncu@respivant.com

858-436-1627

Cleveland Clinic, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Daniel Culver, MD

atutuncu@respivant.com

858-436-1627

Duke University, Durham, North Carolina

Status

Not yet recruiting

Address

Duke University

Durham, North Carolina, 27710

Site Contact

Lake Morrison, MD

atutuncu@respivant.com

858-436-1627

American Health Research, Charlotte, North Carolina

Status

Recruiting

Address

American Health Research

Charlotte, North Carolina, 28207

Site Contact

Selwyn Spangenthal, MD

atutuncu@respivant.com

704-926-8041

New York, New York

Status

Not yet recruiting

Address

Cornell University Weill Cornell Medical College

New York, New York, 10065

Site Contact

Robert Kaner, MD

atutuncu@respivant.com

858-436-1627

St. Luke's Hospital, Chesterfield, Missouri

Status

Recruiting

Address

St. Luke's Hospital

Chesterfield, Missouri, 63017

Site Contact

Neil Ettinger, MD

atutuncu@respivant.com

858-436-1627

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Site Contact

Vivek Iyer

atutuncu@respivant.com

858-436-1627

University of Minnesota, Minneapolis, Minnesota

Status

Not yet recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Hyun Kim

atutuncu@respivant.com

858-436-1627

Universty of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

Universty of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Elizabeth Belloli, MD

atutuncu@respivant.com

858-436-1627

Brigham and Women's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Site Contact

Ivan Rosas

atutuncu@respivant.com

858-436-1627

Massachusetts General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Leo Ginns, MD

atutuncu@respivant.com

858-436-1627

Baltimore, Maryland

Status

Not yet recruiting

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224

Site Contact

Maureen Horton, MD

atutuncu@respivant.com

858-436-1627

Tulane University, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University

New Orleans, Louisiana, 70112

Site Contact

Joseph Lasky

atutuncu@respivant.com

858-436-1627

Loyola University, Maywood, Illinois

Status

Not yet recruiting

Address

Loyola University

Maywood, Illinois, 60153

Site Contact

Daniel Dilling

atutuncu@respivant.com

858-436-1627

University of Miami, Miami, Florida

Status

Not yet recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

Marilyn Glassberg

atutuncu@respivant.com

858-436-1627

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Jeffrey Swigris, MD

atutuncu@respivant.com

858-436-1627

University California San Francisco, San Francisco, California

Status

Not yet recruiting

Address

University California San Francisco

San Francisco, California, 94143

Site Contact

Jeffrey Golden, MD

atutuncu@respivant.com

858-436-1627

University of California Davis, Sacramento, California

Status

Not yet recruiting

Address

University of California Davis

Sacramento, California, 95817

Site Contact

Justin Oldham

atutuncu@respivant.com

858-436-1627

University of Alabama, Birmingham, Alabama

Status

Not yet recruiting

Address

University of Alabama

Birmingham, Alabama, 35294

Site Contact

Pilar Acosta, MD

atutuncu@respivant.com

858-436-1627

International Sites

University Hospital Southampton, Southampton, United Kingdom

Status

Recruiting

Address

University Hospital Southampton

Southampton, ,

Site Contact

Sophie Fletcher, MD

atutuncu@respivant.com

858-436-1627

Nottingham University Hospital, Nottingham, United Kingdom

Status

Recruiting

Address

Nottingham University Hospital

Nottingham, ,

Site Contact

Gauri Saini, MD

atutuncu@respivant.com

858-436-1627

University of Manchester, Manchester, United Kingdom

Status

Recruiting

Address

University of Manchester

Manchester, ,

Site Contact

Nazia Chaudhuri, MD

atutuncu@respivant.com

858-436-1627

Royal Brompton Hospital, London, United Kingdom

Status

Recruiting

Address

Royal Brompton Hospital

London, ,

Site Contact

Toby Maher, MD

atutuncu@respivant.com

858-436-1627

University Hospital Aintree, Liverpool, United Kingdom

Status

Recruiting

Address

University Hospital Aintree

Liverpool, ,

Site Contact

Lisa Spencer, MD

atutuncu@respivant.com

858-436-1627

University of Leicester, Leicester, United Kingdom

Status

Recruiting

Address

University of Leicester

Leicester, ,

Site Contact

Sanjay Agrawal, MD

atutuncu@respivant.com

858-436-1627

University of Edinburgh, Edinburgh, United Kingdom

Status

Not yet recruiting

Address

University of Edinburgh

Edinburgh, ,

Site Contact

Nikhil Hirani

atutuncu@respivant.com

858-436-1627

Royal Papworth Hospital, Cambridge, United Kingdom

Status

Not yet recruiting

Address

Royal Papworth Hospital

Cambridge, ,

Site Contact

Helen Parfrey, MD

atutuncu@respivant.com

858-436-1627

Castle Hill Hospital, Cottingham, East Yorkshire, United Kingdom

Status

Recruiting

Address

Castle Hill Hospital

Cottingham, East Yorkshire,

Site Contact

Simon Hart, MD

atutuncu@respivant.com

858-436-1627

Ege University Hospital, İzmir, Turkey

Status

Not yet recruiting

Address

Ege University Hospital

İzmir, ,

Site Contact

Nesrin Mogulkoc, MD

atutuncu@respivant.com

858-436-1627

Istanbul, Turkey

Status

Not yet recruiting

Address

Istanbul University Istanbul Medical Faculty

Istanbul, ,

Site Contact

Gulfer Okumus, MD

atutuncu@respivant.com

858-436-1627

Cukurova University, Adana, Turkey

Status

Not yet recruiting

Address

Cukurova University

Adana, ,

Site Contact

Ismail Hanta, MD

atutuncu@respivant.com

858-436-1627

Waikato Hospital, Hamilton, New Zealand

Status

Not yet recruiting

Address

Waikato Hospital

Hamilton, ,

Site Contact

Catherina Chang, MD

atutuncu@respivant.com

858-436-1627

University of Otago, Christchurch, New Zealand

Status

Not yet recruiting

Address

University of Otago

Christchurch, ,

Site Contact

Luzt Beckert, MD

atutuncu@respivant.com

858-436-1627

Greenlane Clinical Center, Auckland, New Zealand

Status

Not yet recruiting

Address

Greenlane Clinical Center

Auckland, ,

Site Contact

Sally De Boer, MD

atutuncu@respivant.com

858-436-1627

Erasmus Medical Center, Rotterdam, Netherlands

Status

Recruiting

Address

Erasmus Medical Center

Rotterdam, ,

Site Contact

Marlies Wijsenbeek, MD

atutuncu@respivant.com

858-436-1627

St. Antonius Ziekenhuis, Nieuwegein, Netherlands

Status

Recruiting

Address

St. Antonius Ziekenhuis

Nieuwegein, ,

Site Contact

Marcel Veltkamp, MD

atutuncu@respivant.com

858-436-1627

Zuyderland Medical Center, Heerlen, Netherlands

Status

Recruiting

Address

Zuyderland Medical Center

Heerlen, ,

Site Contact

Remy Mostard, MD

atutuncu@respivant.com

858-436-1627

VU Medical Center, Amsterdam, Netherlands

Status

Recruiting

Address

VU Medical Center

Amsterdam, ,

Site Contact

Esther Nossent, MD

atutuncu@respivant.com

858-436-1627

University of Torino, Torino, Italy

Status

Not yet recruiting

Address

University of Torino

Torino, ,

Site Contact

Carlo Albera, MD

atutuncu@respivant.com

858-436-1627

Siena University Hospital, Siena, Italy

Status

Recruiting

Address

Siena University Hospital

Siena, ,

Site Contact

Elena Bargagli, MD

atutuncu@respivant.com

858-436-1627

Roma, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli

Roma, ,

Site Contact

Luca Richeldi, MD

atutuncu@respivant.com

858-436-1627

University of Padova, Padova, Italy

Status

Not yet recruiting

Address

University of Padova

Padova, ,

Site Contact

Paolo Spagnolo, MD

atutuncu@respivant.com

858-436-1627

A.O.U. Policlinico di Modena, Modena, Italy

Status

Recruiting

Address

A.O.U. Policlinico di Modena

Modena, ,

Site Contact

Stefania Cerri, MD

atutuncu@respivant.com

858-436-1627

University of Catania, Catania, Italy

Status

Recruiting

Address

University of Catania

Catania, ,

Site Contact

Carlo Vancheri, MD

atutuncu@respivant.com

858-436-1627

Bologna University Hospital, Bologna, Italy

Status

Not yet recruiting

Address

Bologna University Hospital

Bologna, ,

Site Contact

Stefano Nava, MD

atutuncu@respivant.com

858-436-1627

Krankenhaus Bethanian, Solingen, Germany

Status

Not yet recruiting

Address

Krankenhaus Bethanian

Solingen, ,

Site Contact

Winfried Randerath, MD

atutuncu@respivant.com

858-436-1627

Lungenfachklinik Immenhausen, Immenhausen, Germany

Status

Not yet recruiting

Address

Lungenfachklinik Immenhausen

Immenhausen, ,

Site Contact

Stefan Andreas, MD

atutuncu@respivant.com

858-436-1627

University Heidelberg, Heidelberg, Germany

Status

Not yet recruiting

Address

University Heidelberg

Heidelberg, ,

Site Contact

Michael Kreuter, MD

atutuncu@respivant.com

858-436-1627

Medizinische Hochshule Hannover, Hannover, Germany

Status

Not yet recruiting

Address

Medizinische Hochshule Hannover

Hannover, ,

Site Contact

Antje Prasse, MD

atutuncu@respivant.com

858-436-1627

Greifenstein, Germany

Status

Recruiting

Address

Pneumologische Klinik Waldhof Elgerhausen

Greifenstein, ,

Site Contact

Andreas Guenther, MD

atutuncu@respivant.com

858-436-1627

Ruhrlandklinik-Universitätsmedizin Essen, Essen, Germany

Status

Not yet recruiting

Address

Ruhrlandklinik-Universitätsmedizin Essen

Essen, ,

Site Contact

Francesco Bonella, MD

atutuncu@respivant.com

858-436-1627

Fachkrankenhaus Coswig, Coswig, Germany

Status

Not yet recruiting

Address

Fachkrankenhaus Coswig

Coswig, ,

Site Contact

Dirk Koschel, MD

atutuncu@respivant.com

858-436-1627

University Clinic Bonn, Bonn, Germany

Status

Not yet recruiting

Address

University Clinic Bonn

Bonn, ,

Site Contact

Dirk Skowasch, MD

atutuncu@respivant.com

858-436-1627

Evangelische Lungerklinik Berlin, Berlin, Germany

Status

Not yet recruiting

Address

Evangelische Lungerklinik Berlin

Berlin, ,

Site Contact

Christian Grohe, MD

atutuncu@respivant.com

858-436-1627

Thomayer Hospital, Prague, Czechia

Status

Recruiting

Address

Thomayer Hospital

Prague, ,

Site Contact

Martina Vasakova, MD

atutuncu@respivant.com

858-436-1627

St. Paul's Hospital, Vancouver, Canada

Status

Not yet recruiting

Address

St. Paul's Hospital

Vancouver, ,

Site Contact

Christopher Ryerson

atutuncu@respivant.com

858-436-1627

Toronto, Canada

Status

Not yet recruiting

Address

University Health Network, Toronto General Hospital

Toronto, ,

Site Contact

Shane Shapera, MD

atutuncu@respivant.com

858-436-1627

Montréal, Canada

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire de Montreal

Montréal, ,

Site Contact

Julie Morisset, MD

atutuncu@respivant.com

858-436-1627

McMaster University, Hamilton, Canada

Status

Not yet recruiting

Address

McMaster University

Hamilton, ,

Site Contact

Martin Kolb, MD

atutuncu@respivant.com

858-436-1627

Dalhousie University, Halifax, Canada

Status

Recruiting

Address

Dalhousie University

Halifax, ,

Site Contact

Paul Hernandez, MD

atutuncu@respivant.com

858-436-1627

University of Alberta, Edmonton, Canada

Status

Not yet recruiting

Address

University of Alberta

Edmonton, ,

Site Contact

Meena Kalluri, MD

atutuncu@respivant.com

858-436-1627

Universitaire Ziekenhuizen Leuven, Leuven, Belgium

Status

Not yet recruiting

Address

Universitaire Ziekenhuizen Leuven

Leuven, ,

Site Contact

Wim Wuyts, MD

atutuncu@respivant.com

858-436-1627

University Clinic Saint-Luc, Brussel, Belgium

Status

Recruiting

Address

University Clinic Saint-Luc

Brussel, ,

Site Contact

Antoine Froidure, MD

atutuncu@respivant.com

858-436-1627

Trialswest, Perth, Western Australia, Australia

Status

Recruiting

Address

Trialswest

Perth, Western Australia, 6150

Site Contact

Peter Bremner, MD

atutuncu@respivant.com

858-436-1627

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

Status

Not yet recruiting

Address

Fiona Stanley Hospital

Murdoch, Western Australia, 6150

Site Contact

Jeremy Wrobel, MD

atutuncu@respivant.com

858-436-1627

Alfred Health, Westmead, Victoria, Australia

Status

Not yet recruiting

Address

Alfred Health

Westmead, Victoria, 3004

Site Contact

Ian Glaspole, MD

atutuncu@respivant.com

858-436-1627

Austin Hospital, Heidelberg, Victoria, Australia

Status

Not yet recruiting

Address

Austin Hospital

Heidelberg, Victoria, 3084

Site Contact

Nicole Goh, MD

atutuncu@respivant.com

858-436-1627

Frankston Hospital-Peninsula Health, Frankston, Victoria, Australia

Status

Not yet recruiting

Address

Frankston Hospital-Peninsula Health

Frankston, Victoria, 3199

Site Contact

David Langton, MD

atutuncu@respivant.com

858-436-1627

Royal Adelaide Hospital, Adelaide, South Australia, Australia

Status

Not yet recruiting

Address

Royal Adelaide Hospital

Adelaide, South Australia, 5000

Site Contact

Mark Holmes, MD

atutuncu@respivant.com

858-436-1627

Mater Research, South Brisbane, Quensland, Australia

Status

Not yet recruiting

Address

Mater Research

South Brisbane, Quensland, 4101

Site Contact

Lucy Burr, MD

atutuncu@respivant.com

858-436-1627

Lung Research Quensland, Chermside, Quensland, Australia

Status

Recruiting

Address

Lung Research Quensland

Chermside, Quensland, 4032

Site Contact

Daniel Chambers, MD

atutuncu@respivant.com

858-436-1627

Westmead Hospital, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Westmead Hospital

Westmead, New South Wales, 2145

Site Contact

John Wheatley, MD

atutuncu@respivant.com

858-436-1627

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Status

Not yet recruiting

Address

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050

Site Contact

Tamera Corte, MD

atutuncu@respivant.com

858-436-1627

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The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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