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



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:40 - 89
Updated:3/10/2019
Start Date:March 2019
End Date:December 2020
Contact:Ahmet Tutuncu, MD, PhD
Email:atutuncu@respivant.com
Phone:858-436-1627

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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

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.


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
We found this trial at
28
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
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185 Cambridge Street
Boston, Massachusetts 02114
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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Durham, North Carolina 27710
(919) 684-8111
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Minneapolis, Minnesota 55455
(612) 625-5000
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
Phone: 864-583-1556
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Ann Arbor, Michigan 48109
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
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Birmingham, Alabama 35294
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28207
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Charlottesville, Virginia 22903
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Chesterfield, Missouri 63017
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Dallas, Texas 75390
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1400 Jackson St
Denver, Colorado 80206
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49 Herestraat
Leuven, 3000
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Maywood, Illinois 60153
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200 First Street SW
Rochester, Minnesota 55905
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Salt Lake City, Utah 84132
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