Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||40 Years - 89 Years|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Respivant Sciences GmbH|
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.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, Belgium, Canada, Czechia, Germany, Italy, Netherlands, New Zealand, Turkey, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Persistent Cough in IPF, Chronic Cough, IPF|
Experimental: RVT-1601 Low Dose
Experimental: RVT-1601 Mid Dose
Experimental: RVT-1601 High Dose
Placebo Comparator: Placebo
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.