Persistent Cough in IPFPhase 2SCENICNCT03864328
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
A Phase 2 study testing RVT-1601 in people with Persistent Cough in IPF and Chronic Cough, run by Respivant Sciences GmbH at 81 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Persistent Cough in IPF, Chronic Cough, IPF
- What is being tested?
- RVT-1601
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 81 sitesin 11 countries
- Study dates
- 29 Mar 2019to 5 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
81 sites in 11 countries.
81 sites in 11 countries
United States28 sites
Universty of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
American Health Research
Charlotte, North Carolina, 28207
University of Virginia
Charlottesville, Virginia, 22903
St. Luke's Hospital
Chesterfield, Missouri, 63017
Cleveland Clinic
Cleveland, Ohio, 44195
UT Southwester Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Duke University
Durham, North Carolina, 27710
Pulmonix, LLC
Greensboro, North Carolina, 27403
Ascension Medical Group / St. Vincent's Lung Institute
Jacksonville, Florida, 32204
Loyola University
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Tulane University
New Orleans, Louisiana, 70112
Cornell University Weill Cornell Medical College
New York, New York, 10065
Renstar Medical Research
Ocala, Florida, 34470
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of California Davis
Sacramento, California, 95817
University of Utah Hospitals & Clinics
Salt Lake City, Utah, 84103
University California San Francisco
San Francisco, California, 94143
University of Washington School of Medicine
Seattle, Washington, 98195
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Tampa General Hospital / Uni of South Florida
Tampa, Florida, 33606
Australia10 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Lung Research Quensland
Chermside, Quensland, 4032
Frankston Hospital-Peninsula Health
Frankston, Victoria, 3199
Austin Hospital
Heidelberg, Victoria, 3084
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Trialswest
Perth, Western Australia, 6150
Mater Research
South Brisbane, Quensland, 4101
Westmead Hospital
Westmead, New South Wales, 2145
Alfred Health
Westmead, Victoria, 3004
United Kingdom9 sites
Royal Papworth Hospital
Cambridge
Castle Hill Hospital
Cottingham, East Yorkshire
University of Edinburgh
Edinburgh
University of Leicester
Leicester
University Hospital Aintree
Liverpool
Royal Brompton Hospital
London
University of Manchester
Manchester
Nottingham University Hospital
Nottingham
University Hospital Southampton
Southampton
Germany8 sites
Evangelische Lungerklinik Berlin
Berlin
University Clinic Bonn
Bonn
Ruhrlandklinik-Universitätsmedizin Essen
Essen
Pneumologische Klinik Waldhof Elgerhausen
Greifenstein
Medizinische Hochshule Hannover
Hanover
University Heidelberg
Heidelberg
Lungenfachklinik Immenhausen
Immenhausen
Krankenhaus Bethanian
Solingen
Italy7 sites
Bologna University Hospital
Bologna
University of Catania
Catania
A.O.U. Policlinico di Modena
Modena
University of Padova
Padova
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Siena University Hospital
Siena
University of Torino
Torino
Canada5 sites
Dalhousie University
Halifax
McMaster University
Hamilton
Centre Hospitalier Universitaire de Montreal
Montreal
University Health Network, Toronto General Hospital
Toronto
St. Paul's Hospital
Vancouver
Netherlands5 sites
VU Medical Center
Amsterdam
Zuyderland Medical Center
Heerlen
St. Antonius Ziekenhuis
Nieuwegein
Erasmus Medical Center
Rotterdam
Haaglanden Medical Center
The Hague
New Zealand3 sites
Greenlane Clinical Center
Auckland
University of Otago
Christchurch
Waikato Hospital
Hamilton
Turkey (Türkiye)3 sites
Cukurova University
Adana
Istanbul University Istanbul Medical Faculty
Istanbul
Ege University Hospital
Izmir
Belgium2 sites
University Clinic Saint-Luc
Brussels
Universitaire Ziekenhuizen Leuven
Leuven
About this study
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
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
- Being tested
- RVT-1601, Placebo
- Keywords
- Cough, Chronic Cough, IPF, IPF Cough
- Medical subject headings
- Chronic Cough, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-1601Drug
Inhaled RVT-1601 administered TID via eFlow nebulizer
PlaceboDrug
Inhaled Placebo administered TID via eFlow nebulizer
| Study group | Role | What they receive |
|---|---|---|
| RVT-1601 Low Dose | Experimental | Not described Receives: Drug: RVT-1601 |
| RVT-1601 Mid Dose | Experimental | Not described Receives: Drug: RVT-1601 |
| RVT-1601 High Dose | Experimental | Not described Receives: Drug: RVT-1601 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour average cough count
Objective cough count monitoring performed using a digital recording device.
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start29 Mar 2019
- Primary completion29 May 2020
- Study completion5 Jun 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Cough in IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization stratified by background IPF therapy use and FVC % predicted at baseline
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Respivant Sciences Inc.
- Responsible party
- Sponsor
- Investigators
- Ahmet Tutuncu, MD, PhD, Study director, Respivant Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864328
- Sponsor's protocol ID
- RVT1601-CC-04
- Acronym
- SCENIC
- Status last verified
- Jun 2020
- First submitted
- 2 Mar 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03864328
- Acronym / sponsor ID
- SCENIC / RVT1601-CC-04
- Conditions
- Persistent Cough in IPF, Chronic Cough, IPF
- Keywords
- Cough, Chronic Cough, IPF, IPF Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Respivant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Respivant Sciences Inc.
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomization stratified by background IPF therapy use and FVC % predicted at baseline
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVT-1601Inhaled RVT-1601 administered TID via eFlow nebulizer | Drug | RVT-1601 High Dose, RVT-1601 Low Dose, RVT-1601 Mid Dose |
| PlaceboInhaled Placebo administered TID via eFlow nebulizer | Drug | Placebo |
Primary outcome
Change in 24-hour average cough count
Time frame: 12 weeks
Objective cough count monitoring performed using a digital recording device.
2 secondary outcomes
Change in cough severity
Time frame: 12 weeks
Change in cough-specific QoL
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Tutuncu, MD, PhD study director
Respivant Sciences Inc.
81 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVT-1601 in people with Persistent Cough in IPF and Chronic Cough, run by Respivant Sciences GmbH at 81 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Australia, United Kingdom, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour average cough count (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.