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

Chronic Cough Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03864328
• Other study ID #: RVT1601-CC-04
• Status: Terminated
• Phase: Phase 2
• Start date: March 29, 2019
• Est. completion date: June 5, 2020

Study information

• Verified date: June 2020
• Source: Respivant Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: June 5, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough
• IPF
• Persistent Cough in IPF

Intervention

Drug:
• RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer
• Placebo
Inhaled Placebo administered TID via eFlow nebulizer

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Lung Research Quensland	Chermside	Quensland
Australia	Frankston Hospital-Peninsula Health	Frankston	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Trialswest	Perth	Western Australia
Australia	Mater Research	South Brisbane	Quensland
Australia	Alfred Health	Westmead	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	University Clinic Saint-Luc	Brussel
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Canada	Dalhousie University	Halifax
Canada	McMaster University	Hamilton
Canada	Centre Hospitalier Universitaire de Montreal	Montréal
Canada	University Health Network, Toronto General Hospital	Toronto
Canada	St. Paul's Hospital	Vancouver
Czechia	Thomayer Hospital	Prague
Germany	Evangelische Lungerklinik Berlin	Berlin
Germany	University Clinic Bonn	Bonn
Germany	Ruhrlandklinik-Universitätsmedizin Essen	Essen
Germany	Pneumologische Klinik Waldhof Elgerhausen	Greifenstein
Germany	Medizinische Hochshule Hannover	Hannover
Germany	University Heidelberg	Heidelberg
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Krankenhaus Bethanian	Solingen
Italy	Bologna University Hospital	Bologna
Italy	University of Catania	Catania
Italy	A.O.U. Policlinico di Modena	Modena
Italy	University of Padova	Padova
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	Siena University Hospital	Siena
Italy	University of Torino	Torino
Netherlands	VU Medical Center	Amsterdam
Netherlands	Haaglanden Medical Center	Den Haag
Netherlands	Zuyderland Medical Center	Heerlen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
New Zealand	Greenlane Clinical Center	Auckland
New Zealand	University of Otago	Christchurch
New Zealand	Waikato Hospital	Hamilton
Turkey	Cukurova University	Adana
Turkey	Istanbul University Istanbul Medical Faculty	Istanbul
Turkey	Ege University Hospital	Izmir
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Castle Hill Hospital	Cottingham	East Yorkshire
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 States	Universty of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	American Health Research	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Cleveland Clinic	Cleveland	Ohio
United States	UT Southwester Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Pulmonix, LLC	Greensboro	North Carolina
United States	Ascension Medical Group / St. Vincent's Lung Institute	Jacksonville	Florida
United States	Loyola University	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Cornell University Weill Cornell Medical College	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	University of California Davis	Sacramento	California
United States	University of Utah Hospitals & Clinics	Salt Lake City	Utah
United States	University California San Francisco	San Francisco	California
United States	University of Washington School of Medicine	Seattle	Washington
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Tampa General Hospital / Uni of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Respivant Sciences GmbH	Respivant Sciences Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Germany,  Italy,  Netherlands,  New Zealand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in forced vital capacity (FVC)	FVC measured as the total amount of air exhaled during pulmonary function test.	12 weeks
Other	Change in disease-specific QoL	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.	12 weeks
Other	Change in airway and lung volumes as measured by HRCT images	HRCT-based functional respiratory imaging (FRI) parameters measured at end-inspiration and end-expiration.	12 weeks
Other	Change in biomarkers	Collagen degradation by-products measured in the blood.	12 weeks
Other	Change in respiratory-related QoL	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.	12 weeks
Other	Change in dyspnea score	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).	12 weeks
Primary	Change in 24-hour average cough count	Objective cough count monitoring performed using a digital recording device.	12 weeks
Secondary	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).	12 weeks
Secondary	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.	12 weeks