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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 89 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03864328
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Respivant Sciences GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ahmet Tutuncu, MD, PhD
Principal Investigator Affiliation	Respivant Sciences Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Canada, Czechia, Germany, Italy, Netherlands, New Zealand, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Persistent Cough in IPF, Chronic Cough, IPF

Arms & Interventions

Arms

Experimental: RVT-1601 Low Dose

Experimental: RVT-1601 Mid Dose

Experimental: RVT-1601 High Dose

Placebo Comparator: Placebo

Interventions

Drug: - RVT-1601

Inhaled RVT-1601 administered TID via eFlow nebulizer

Drug: - Placebo

Inhaled Placebo administered TID via eFlow nebulizer

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama

Birmingham, Alabama, 35294

Site Contact

Pilar Acosta, MD