A Study of Experimental Inhaled RVT-1601 for Idiopathic Pulmonary Fibrosis (IPF)

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Age: 40 to 89 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis, IPF, pulmonary fibrosis
Type: Drug study, Phase 2
Target:
8 Participants
Investigator:
Description
Idiopathic pulmonary fibrosis (IPF) is a disease that causes scarring in the lungs. It leads to shortness of breath and a persistent cough (a cough that occurs for a long period of time).

The purpose of this research study is to test the effects of the study drug, experimental RVT-1601. It will be compared to placebo (a product with no active medication). It will be studied in patients with persistent cough due to IPF on improving cough (frequency and severity) and quality of life.

We also want to find out the best dose of RVT-1601 and its levels in the blood over time, and to collect additional safety information about the drug. Another goal is to determine the anti-fibrotic (scar-fighting) activity of RVT-1601. We want to see if it slows the worsening (progression) of IPF disease by measuring your lung symptoms, quality of life, and breathing tests.

Experimental RVT-1601 is a new formulation of cromolyn sodium, a medicine used to treat asthma in children and adults. RVT1601 is an experimental drug (a drug that has not been approved by the FDA but has been approved for this trial to treat IPF).

The way cromolyn sodium works in the human body is not completely known. It does slow the development of swelling, redness, and scarring in the airways and lungs and suppresses the nerve endings in the lungs. It may make patients cough less and slow the scarring of the lungs. RVT-1601 is delivered as a mist through an eFlow® nebulizer. Patients will inhale through a mouthpiece attached to the nebulizer. Each dose of RVT-1601 is inhaled for approximately 3 minutes three times a day.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you up to a total of $1900 for your time and effort. Your compensation will be broken down as follows: • Screening (visit 0) and visits 2, 3, 4, 7, 9, and 11 (or early termination): $200 each • Visits 1, 5, 6, 8, 10: $100 each If you stop participating in the study, you will only be paid for the visits that you completed.
Resources
Schedule
Study duration and period
If you decide to participate in the study, you will sign this consent form and begin the Screening period. The Screening period will last up to 4 weeks, in order to give the study doctor time to determine if you qualify for the study. After the Screening Period, we expect that you will participate in the study for approximately 24 weeks (6 months). Your total study participation is expected to be 28 weeks (7 months).
Recruitment period
From July 22, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Chelsea Thompson
Research Topic
Conditions:
  • Persistent Cough in IPF
  • Chronic Cough
  • IPF