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

Primary Purpose

Persistent Cough in IPF, Chronic Cough, IPF

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RVT-1601
Placebo
Sponsored by
Respivant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Cough in IPF focused on measuring Cough, Chronic Cough, IPF, IPF Cough

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • University of California Davis
  • University California San Francisco
  • National Jewish Health
  • Ascension Medical Group / St. Vincent's Lung Institute
  • University of Miami
  • Renstar Medical Research
  • Tampa General Hospital / Uni of South Florida
  • Loyola University
  • Tulane University
  • Johns Hopkins University School of Medicine
  • Brigham and Women's Hospital
  • Universty of Michigan
  • Mayo Clinic - Rochester
  • St. Luke's Hospital
  • Cornell University Weill Cornell Medical College
  • American Health Research
  • Duke University
  • Pulmonix, LLC
  • Cleveland Clinic
  • Temple University School of Medicine
  • Medical University of South Carolina
  • Spartanburg Medical Research
  • Vanderbilt University Medical Center
  • UT Southwester Medical Center
  • University of Utah Hospitals & Clinics
  • University of Virginia
  • University of Washington School of Medicine
  • Royal Prince Alfred Hospital
  • Westmead Hospital
  • Lung Research Quensland
  • Mater Research
  • Royal Adelaide Hospital
  • Frankston Hospital-Peninsula Health
  • Austin Hospital
  • Alfred Health
  • Fiona Stanley Hospital
  • Trialswest
  • University Clinic Saint-Luc
  • Universitaire Ziekenhuizen Leuven
  • Dalhousie University
  • McMaster University
  • Centre Hospitalier Universitaire de Montreal
  • University Health Network, Toronto General Hospital
  • St. Paul's Hospital
  • Thomayer Hospital
  • Evangelische Lungerklinik Berlin
  • University Clinic Bonn
  • Ruhrlandklinik-Universitätsmedizin Essen
  • Pneumologische Klinik Waldhof Elgerhausen
  • Medizinische Hochshule Hannover
  • University Heidelberg
  • Lungenfachklinik Immenhausen
  • Krankenhaus Bethanian
  • Bologna University Hospital
  • University of Catania
  • A.O.U. Policlinico di Modena
  • University of Padova
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Siena University Hospital
  • University of Torino
  • VU Medical Center
  • Haaglanden Medical Center
  • Zuyderland Medical Center
  • St. Antonius Ziekenhuis
  • Erasmus Medical Center
  • Greenlane Clinical Center
  • University of Otago
  • Waikato Hospital
  • Cukurova University
  • Istanbul University Istanbul Medical Faculty
  • Ege University Hospital
  • Castle Hill Hospital
  • Royal Papworth Hospital
  • University of Edinburgh
  • University of Leicester
  • University Hospital Aintree
  • Royal Brompton Hospital
  • University of Manchester
  • Nottingham University Hospital
  • University Hospital Southampton

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

RVT-1601 Low Dose

RVT-1601 Mid Dose

RVT-1601 High Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in 24-hour average cough count
Objective cough count monitoring performed using a digital recording device.

Secondary Outcome Measures

Change in cough severity
Cough severity assessed using Visual Analog Scale (VAS), a single-item questionnaire using 100-point scale ranging from 0 (no cough) to 100 (extremely severe cough).
Change in cough-specific QoL
Cough-specific QoL assessed using Leicester Cough Questionnaire (LCQ), a 19-item questionnaire designed to measure impact of cough in three domains (physical, psychological and social), each domain ranging from 1 to 7 and LCQ total score ranging from 3 to 21, with the higher scores corresponding with better QoL.

Full Information

First Posted
March 2, 2019
Last Updated
June 8, 2020
Sponsor
Respivant Sciences GmbH
Collaborators
Respivant Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03864328
Brief Title
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Acronym
SCENIC
Official Title
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 Pandemic
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
June 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respivant Sciences GmbH
Collaborators
Respivant Sciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Cough in IPF, Chronic Cough, IPF
Keywords
Cough, Chronic Cough, IPF, IPF Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomization stratified by background IPF therapy use and FVC % predicted at baseline
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RVT-1601 Low Dose
Arm Type
Experimental
Arm Title
RVT-1601 Mid Dose
Arm Type
Experimental
Arm Title
RVT-1601 High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RVT-1601
Intervention Description
Inhaled RVT-1601 administered TID via eFlow nebulizer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhaled Placebo administered TID via eFlow nebulizer
Primary Outcome Measure Information:
Title
Change in 24-hour average cough count
Description
Objective cough count monitoring performed using a digital recording device.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in cough severity
Description
Cough severity assessed using Visual Analog Scale (VAS), a single-item questionnaire using 100-point scale ranging from 0 (no cough) to 100 (extremely severe cough).
Time Frame
12 weeks
Title
Change in cough-specific QoL
Description
Cough-specific QoL assessed using Leicester Cough Questionnaire (LCQ), a 19-item questionnaire designed to measure impact of cough in three domains (physical, psychological and social), each domain ranging from 1 to 7 and LCQ total score ranging from 3 to 21, with the higher scores corresponding with better QoL.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Change in forced vital capacity (FVC)
Description
FVC measured as the total amount of air exhaled during pulmonary function test.
Time Frame
12 weeks
Title
Change in disease-specific QoL
Description
Disease-specific QoL assessed using King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-item questionnaire designed to measure impact of interstitial lung disease in three domains (breathlessness and activities, psychological and chest symptoms), each domain and total score ranging from 0 to 100 with the higher scores corresponding with better QoL.
Time Frame
12 weeks
Title
Change in airway and lung volumes as measured by HRCT images
Description
HRCT-based functional respiratory imaging (FRI) parameters measured at end-inspiration and end-expiration.
Time Frame
12 weeks
Title
Change in biomarkers
Description
Collagen degradation by-products measured in the blood.
Time Frame
12 weeks
Title
Change in respiratory-related QoL
Description
Respiratory-related QoL assessed using St. George's Respiratory Questionnaire (SGRQ), a 50-item questionnaire designed to measure impact of respiratory symptoms on overall health, daily life, and perceived well-being, with total score ranging from 0 to 100 and lower score denoting a better health status.
Time Frame
12 weeks
Title
Change in dyspnea score
Description
Dyspnea score assessed using University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ),a 24-item questionnaire designed to measure breathlessness on a scale from 0 (not at all breathless) to 5 (maximally breathless or too breathless to do the activity).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Tutuncu, MD, PhD
Organizational Affiliation
Respivant Sciences Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Ascension Medical Group / St. Vincent's Lung Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Tampa General Hospital / Uni of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Universty of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Cornell University Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pulmonix, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwester Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah Hospitals & Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Lung Research Quensland
City
Chermside
State/Province
Quensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Mater Research
City
South Brisbane
State/Province
Quensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Frankston Hospital-Peninsula Health
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Health
City
Westmead
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Trialswest
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
University Clinic Saint-Luc
City
Brussel
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
Country
Belgium
Facility Name
Dalhousie University
City
Halifax
Country
Canada
Facility Name
McMaster University
City
Hamilton
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Montreal
City
Montréal
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
Country
Canada
Facility Name
Thomayer Hospital
City
Prague
Country
Czechia
Facility Name
Evangelische Lungerklinik Berlin
City
Berlin
Country
Germany
Facility Name
University Clinic Bonn
City
Bonn
Country
Germany
Facility Name
Ruhrlandklinik-Universitätsmedizin Essen
City
Essen
Country
Germany
Facility Name
Pneumologische Klinik Waldhof Elgerhausen
City
Greifenstein
Country
Germany
Facility Name
Medizinische Hochshule Hannover
City
Hannover
Country
Germany
Facility Name
University Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
Country
Germany
Facility Name
Krankenhaus Bethanian
City
Solingen
Country
Germany
Facility Name
Bologna University Hospital
City
Bologna
Country
Italy
Facility Name
University of Catania
City
Catania
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
Country
Italy
Facility Name
University of Padova
City
Padova
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Siena University Hospital
City
Siena
Country
Italy
Facility Name
University of Torino
City
Torino
Country
Italy
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Haaglanden Medical Center
City
Den Haag
Country
Netherlands
Facility Name
Zuyderland Medical Center
City
Heerlen
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Greenlane Clinical Center
City
Auckland
Country
New Zealand
Facility Name
University of Otago
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Cukurova University
City
Adana
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
Country
Turkey
Facility Name
Ege University Hospital
City
İzmir
Country
Turkey
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
East Yorkshire
Country
United Kingdom
Facility Name
Royal Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
University of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
University of Leicester
City
Leicester
Country
United Kingdom
Facility Name
University Hospital Aintree
City
Liverpool
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
University of Manchester
City
Manchester
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
Country
United Kingdom
Facility Name
University Hospital Southampton
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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