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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03864328
• Date of registration: 02/03/2019
• Prospective Registration: Yes
• Primary sponsor: Respivant Sciences GmbH
• Public title: A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF SCENIC
• 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
• Date of first enrolment: March 29, 2019
• Target sample size: 108
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03864328
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Ahmet Tutuncu, MD, PhD
• Affiliation: Respivant Sciences Inc.

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Persistent Cough in IPF

IPF

Chronic Cough

Intervention(s)

Drug: Placebo

Drug: RVT-1601

Primary Outcome(s)

Change in 24-hour average cough count [Time Frame: 12 weeks]

Secondary Outcome(s)

Change in cough-specific QoL [Time Frame: 12 weeks]

Change in cough severity [Time Frame: 12 weeks]

Secondary ID(s)

RVT1601-CC-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Respivant Sciences Inc.