Clinical trial NCT03864328: A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Persistent Cough in IPF
Chronic Cough
IPF
Keywords: Cough
Chronic Cough
IPF
IPF Cough
Lead sponsor: Respivant Sciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: Respivant Sciences Inc.
First posted: 2019-03-06
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization stratified by background IPF therapy use and FVC % predicted at baseline
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in 24-hour average cough count
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in cough severity
timeFrame: 12 weeks
measure: Change in cough-specific QoL
timeFrame: 12 weeks
Other outcomes:
measure: Change in forced vital capacity (FVC)
timeFrame: 12 weeks
measure: Change in disease-specific QoL
timeFrame: 12 weeks
measure: Change in airway and lung volumes as measured by HRCT images
timeFrame: 12 weeks
measure: Change in biomarkers
timeFrame: 12 weeks
measure: Change in respiratory-related QoL
timeFrame: 12 weeks
measure: Change in dyspnea score
timeFrame: 12 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: University California San Francisco
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Jacksonville
country: United States
facility: Ascension Medical Group / St. Vincent's Lung Institute
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital / Uni of South Florida
state: Florida
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Universty of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital
state: Missouri
city: New York
country: United States
facility: Cornell University Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: Pulmonix, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwester Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals & Clinics
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: Lung Research Quensland
state: Quensland
city: South Brisbane
country: Australia
facility: Mater Research
state: Quensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital-Peninsula Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Westmead
country: Australia
facility: Alfred Health
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Perth
country: Australia
facility: Trialswest
state: Western Australia
city: Brussel
country: Belgium
facility: University Clinic Saint-Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Halifax
country: Canada
facility: Dalhousie University
city: Hamilton
country: Canada
facility: McMaster University
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de Montreal
city: Toronto
country: Canada
facility: University Health Network, Toronto General Hospital
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Prague
country: Czechia
facility: Thomayer Hospital
city: Berlin
country: Germany
facility: Evangelische Lungerklinik Berlin
city: Bonn
country: Germany
facility: University Clinic Bonn
city: Essen
country: Germany
facility: Ruhrlandklinik-Universitätsmedizin Essen
city: Greifenstein
country: Germany
facility: Pneumologische Klinik Waldhof Elgerhausen
city: Hannover
country: Germany
facility: Medizinische Hochshule Hannover
city: Heidelberg
country: Germany
facility: University Heidelberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Solingen
country: Germany
facility: Krankenhaus Bethanian
city: Bologna
country: Italy
facility: Bologna University Hospital
city: Catania
country: Italy
facility: University of Catania
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
city: Padova
country: Italy
facility: University of Padova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Siena
country: Italy
facility: Siena University Hospital
city: Torino
country: Italy
facility: University of Torino
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Auckland
country: New Zealand
facility: Greenlane Clinical Center
city: Christchurch
country: New Zealand
facility: University of Otago
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Adana
country: Turkey
facility: Cukurova University
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: İzmir
country: Turkey
facility: Ege University Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
city: Leicester
country: United Kingdom
facility: University of Leicester
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Manchester
country: United Kingdom
facility: University of Manchester
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Respivant Sciences Inc.
name: Ahmet Tutuncu, MD, PhD
role: STUDY_DIRECTOR
References: