Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomization stratified by background IPF therapy use and FVC % predicted at baseline
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Tulane University
New Orleans, Louisiana 70112
Contact:
Joseph Lasky

More Details

NCT ID
NCT03864328
Status
Recruiting
Sponsor
Respivant Sciences GmbH

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.