A Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in Idiopathic Pulmonary Fibrosis (IPF)

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 19-000371
    NCT ID: NCT03864328
    Sponsor Protocol Number: RVT1601

About this study

The purpose of this study is to evaluate Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, for the treatment of persistent cough in patients with idiopathic pulmonary fibrosis (IPF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vivek Iyer, M.D., M.P.H.

Open for enrollment

Contact information:

Pulmonary Research Unit

(507) 284-9009

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available