Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03864328 |
Date of registration:
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02/03/2019 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
SCENIC |
Scientific title:
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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 |
Date of first enrolment:
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March 29, 2019 |
Target sample size:
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108 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03864328 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Canada
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Czechia
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Germany
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Italy
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Netherlands
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New Zealand
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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Ahmet Tutuncu, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Respivant Sciences Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
89 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Persistent Cough in IPF
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IPF
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Chronic Cough
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Intervention(s)
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Drug: Placebo
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Drug: RVT-1601
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Primary Outcome(s)
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Change in 24-hour average cough count
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change in cough-specific QoL
[Time Frame: 12 weeks]
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Change in cough severity
[Time Frame: 12 weeks]
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Secondary ID(s)
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RVT1601-CC-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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