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

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ClinicalTrials.gov Identifier: NCT03864328
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Respivant Sciences Inc.
Information provided by (Responsible Party):
Respivant Sciences Inc. ( Respivant Sciences GmbH )

Tracking Information
First Submitted Date  ICMJE March 2, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE March 29, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
Change in 24-hour average cough count [ Time Frame: 12 weeks ]
Objective cough count monitoring performed using a digital recording device.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03864328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Change in cough severity [ Time Frame: 12 weeks ]
    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).
  • Change in cough-specific QoL [ Time Frame: 12 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 4, 2019)
  • Change in forced vital capacity (FVC) [ Time Frame: 12 weeks ]
    FVC measured as the total amount of air exhaled during pulmonary function test.
  • Change in disease-specific QoL [ Time Frame: 12 weeks ]
    Disease-specific QoL assessed using King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-item questionnaire designed to measure impact of interstitial lung disease in three domains (breathlessness and activities, psychological and chest symptoms), each domain and total score ranging from 0 to 100 with the higher scores corresponding with better QoL.
  • Change in airway and lung volumes as measured by HRCT images [ Time Frame: 12 weeks ]
    HRCT-based functional respiratory imaging (FRI) parameters measured at end-inspiration and end-expiration.
  • Change in biomarkers [ Time Frame: 12 weeks ]
    Collagen degradation by-products measured in the blood.
  • Change in respiratory-related QoL [ Time Frame: 12 weeks ]
    Respiratory-related QoL assessed using St. George's Respiratory Questionnaire (SGRQ), a 50-item questionnaire designed to measure impact of respiratory symptoms on overall health, daily life, and perceived well-being, with total score ranging from 0 to 100 and lower score denoting a better health status.
  • Change in dyspnea score [ Time Frame: 12 weeks ]
    Dyspnea score assessed using University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ),a 24-item questionnaire designed to measure breathlessness on a scale from 0 (not at all breathless) to 5 (maximally breathless or too breathless to do the activity).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomization stratified by background IPF therapy use and FVC % predicted at baseline
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Persistent Cough in IPF
  • Chronic Cough
  • IPF
Intervention  ICMJE
  • Drug: RVT-1601
    Inhaled RVT-1601 administered TID via eFlow nebulizer
  • Drug: Placebo
    Inhaled Placebo administered TID via eFlow nebulizer
Study Arms  ICMJE
  • Experimental: RVT-1601 Low Dose
    Intervention: Drug: RVT-1601
  • Experimental: RVT-1601 Mid Dose
    Intervention: Drug: RVT-1601
  • Experimental: RVT-1601 High Dose
    Intervention: Drug: RVT-1601
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmet Tutuncu, MD, PhD 858-436-1627 atutuncu@respivant.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Germany,   Italy,   Netherlands,   New Zealand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03864328
Other Study ID Numbers  ICMJE RVT1601-CC-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Respivant Sciences Inc. ( Respivant Sciences GmbH )
Study Sponsor  ICMJE Respivant Sciences GmbH
Collaborators  ICMJE Respivant Sciences Inc.
Investigators  ICMJE
Study Director: Ahmet Tutuncu, MD, PhD Respivant Sciences Inc.
PRS Account Respivant Sciences Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP