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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 )

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.


Condition or disease Intervention/treatment Phase
Persistent Cough in IPF Chronic Cough IPF Drug: RVT-1601 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
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
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
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: RVT-1601 Low Dose Drug: RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer

Experimental: RVT-1601 Mid Dose Drug: RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer

Experimental: RVT-1601 High Dose Drug: RVT-1601
Inhaled RVT-1601 administered TID via eFlow nebulizer

Placebo Comparator: Placebo Drug: Placebo
Inhaled Placebo administered TID via eFlow nebulizer




Primary Outcome Measures :
  1. Change in 24-hour average cough count [ Time Frame: 12 weeks ]
    Objective cough count monitoring performed using a digital recording device.


Secondary Outcome Measures :
  1. 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).

  2. 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.


Other Outcome Measures:
  1. Change in forced vital capacity (FVC) [ Time Frame: 12 weeks ]
    FVC measured as the total amount of air exhaled during pulmonary function test.

  2. 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.

  3. 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.

  4. Change in biomarkers [ Time Frame: 12 weeks ]
    Collagen degradation by-products measured in the blood.

  5. 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.

  6. 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).



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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864328


Contacts
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Contact: Ahmet Tutuncu, MD, PhD 858-436-1627 atutuncu@respivant.com

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Birmingham, Alabama, United States, 35294
Contact: Pilar Acosta, MD         
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Sacramento, California, United States, 95817
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San Francisco, California, United States, 94143
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Denver, Colorado, United States, 80206
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Miami, Florida, United States, 33136
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Maywood, Illinois, United States, 60153
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New Orleans, Louisiana, United States, 70112
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Baltimore, Maryland, United States, 21224
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Sponsors and Collaborators
Respivant Sciences GmbH
Respivant Sciences Inc.
Investigators
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Study Director: Ahmet Tutuncu, MD, PhD Respivant Sciences Inc.

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Responsible Party: Respivant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03864328     History of Changes
Other Study ID Numbers: RVT1601-CC-04
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Respivant Sciences Inc. ( Respivant Sciences GmbH ):
Cough
Chronic Cough
IPF
IPF Cough
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms