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

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

  • Persistent Cough in IPF
  • Chronic Cough
  • IPF

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

More Details

Status
Terminated
Sponsor
Respivant Sciences GmbH

Study Contact