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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03864328




Registration number
NCT03864328
Ethics application status
Date submitted
2/03/2019
Date registered
6/03/2019
Date last updated
11/06/2020

Titles & IDs
Public title
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Scientific 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
Secondary ID [1] 0 0
RVT1601-CC-04
Universal Trial Number (UTN)
Trial acronym
SCENIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Cough in IPF 0 0
Chronic Cough 0 0
IPF 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RVT-1601
Treatment: Drugs - Placebo

Experimental: RVT-1601 Low Dose -

Experimental: RVT-1601 Mid Dose -

Experimental: RVT-1601 High Dose -

Placebo Comparator: Placebo -


Treatment: Drugs: RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer

Treatment: Drugs: Placebo
Inhaled Placebo administered TID via eFlow nebulizer
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in 24-hour average cough count
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Change in cough severity
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change in cough-specific QoL
Timepoint [2] 0 0
12 weeks

Eligibility
Key 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
Minimum age
40 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/06/2020
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW,QuenslandSA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Lung Research Quensland - Chermside
Recruitment hospital [4] 0 0
Mater Research - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Frankston Hospital-Peninsula Health - Frankston
Recruitment hospital [7] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [8] 0 0
Alfred Health - Westmead
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
Trialswest - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3004 - Westmead
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6150 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Illinois
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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North Carolina
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Ohio
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Pennsylvania
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Germany
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Bonn
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Germany
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Essen
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Germany
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Greifenstein
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Germany
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Hannover
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Heidelberg
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Germany
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Immenhausen
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Germany
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Solingen
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Bologna
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Catania
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Italy
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Modena
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Italy
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Padova
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Roma
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Italy
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Siena
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Den Haag
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Heerlen
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Rotterdam
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Auckland
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New Zealand
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Christchurch
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Hamilton
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Turkey
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Adana
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Istanbul
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Izmir
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Cambridge
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Nottingham
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Respivant Sciences GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Respivant Sciences Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03864328
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ahmet Tutuncu, MD, PhD
Address 0 0
Respivant Sciences Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03864328