Trial | NCT03864328  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    108
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.
Study Started
Mar 29
2019
Primary Completion
May 29
2020
Study Completion
Jun 05
2020
Last Update
Jun 11
2020

Drug RVT-1601

Inhaled RVT-1601 administered TID via eFlow nebulizer

Drug Placebo

Inhaled Placebo administered TID via eFlow nebulizer

RVT-1601 Low Dose Experimental

RVT-1601 Mid Dose Experimental

RVT-1601 High Dose Experimental

Placebo Placebo Comparator

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
No Results Posted