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

NCT03864328 | Terminated Phase 2 FDA Drug

• 1 other identifier: RVT1601-CC-04
• Study Type: interventional
• Target: 108
• Locations: 11 countries
• Sites: 81

Brief 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.

Conditions

Persistent Cough in IPF; Chronic Cough; IPF

Keywords

Cough; Chronic Cough; IPF; IPF Cough

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour average cough count

  Objective cough count monitoring performed using a digital recording device.

  12 weeks

Secondary Outcomes (2)

• Change in cough severity

  12 weeks

• Change in cough-specific QoL

  12 weeks

Other Outcomes (6)

• Change in forced vital capacity (FVC)

  12 weeks

• Change in disease-specific QoL

  12 weeks

• Change in airway and lung volumes as measured by HRCT images

  12 weeks

Study Arms (4)

RVT-1601 Low Dose

EXPERIMENTAL

Drug: RVT-1601

RVT-1601 Mid Dose

EXPERIMENTAL

Drug: RVT-1601

RVT-1601 High Dose

EXPERIMENTAL

Drug: RVT-1601

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RVT-1601 DRUG

Inhaled RVT-1601 administered TID via eFlow nebulizer

RVT-1601 High Dose; RVT-1601 Low Dose; RVT-1601 Mid Dose

Placebo DRUG

Inhaled Placebo administered TID via eFlow nebulizer

Placebo

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Respivant Sciences GmbH: lead
• Respivant Sciences Inc.: collaborator

Study Sites (81)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University California San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Ascension Medical Group / St. Vincent's Lung Institute

Jacksonville, Florida, 32204, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Tampa General Hospital / Uni of South Florida

Tampa, Florida, 33606, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Universty of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Cornell University Weill Cornell Medical College

New York, New York, 10065, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Pulmonix, LLC

Greensboro, North Carolina, 27403, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwester Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah Hospitals & Clinics

Salt Lake City, Utah, 84103, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98195, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Lung Research Quensland

Chermside, Quensland, 4032, Australia

Location

Mater Research

South Brisbane, Quensland, 4101, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Frankston Hospital-Peninsula Health

Frankston, Victoria, 3199, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Westmead, Victoria, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Trialswest

Perth, Western Australia, 6150, Australia

Location

University Clinic Saint-Luc

Brussels, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Location

Dalhousie University

Halifax, Canada

Location

McMaster University

Hamilton, Canada

Location

Centre Hospitalier Universitaire de Montreal

Montreal, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Canada

Location

St. Paul's Hospital

Vancouver, Canada

Location

Thomayer Hospital

Prague, Czechia

Location

Evangelische Lungerklinik Berlin

Berlin, Germany

Location

University Clinic Bonn

Bonn, Germany

Location

Ruhrlandklinik-Universitätsmedizin Essen

Essen, Germany

Location

Pneumologische Klinik Waldhof Elgerhausen

Greifenstein, Germany

Location

Medizinische Hochshule Hannover

Hanover, Germany

Location

University Heidelberg

Heidelberg, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Germany

Location

Krankenhaus Bethanian

Solingen, Germany

Location

Bologna University Hospital

Bologna, Italy

Location

University of Catania

Catania, Italy

Location

A.O.U. Policlinico di Modena

Modena, Italy

Location

University of Padova

Padua, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Siena University Hospital

Siena, Italy

Location

University of Torino

Torino, Italy

Location

VU Medical Center

Amsterdam, Netherlands

Location

Zuyderland Medical Center

Heerlen, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Haaglanden Medical Center

The Hague, Netherlands

Location

Greenlane Clinical Center

Auckland, New Zealand

Location

University of Otago

Christchurch, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Cukurova University

Adana, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Ege University Hospital

Izmir, Turkey (Türkiye)

Location

Castle Hill Hospital

Cottingham, East Yorkshire, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

University of Leicester

Leicester, United Kingdom

Location

University Hospital Aintree

Liverpool, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

University of Manchester

Manchester, United Kingdom

Location

Nottingham University Hospital

Nottingham, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Chronic Cough; Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmet Tutuncu, MD, PhD

  Respivant Sciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization stratified by background IPF therapy use and FVC % predicted at baseline

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 6, 2019
• Study Start: March 29, 2019
• Primary Completion: May 29, 2020
• Study Completion: June 5, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10); BE (2); DE (8); US (28); IT (7); CZ (1); NZ (3); CA (5); NL (5); TU (3); GB (9)