A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated … (NCT05747508) | Clinical Trial Compass
UnknownPhase 2
A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
United States85 participantsStarted 2017-12-29
Plain-language summary
A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
* Major idiopathic interstitial pneumonias (IIPs) diagnosis or suspected as one of the following:
* Idiopathic pulmonary fibrosis
* Idiopathic nonspecific interstitial pneumonia
* Respiratory bronchiolitis-interstitial lung disease
* Desquamative interstitial pneumonia
* Cryptogenic organizing pneumonia
* Acute interstitial pneumonia
* Rare IIPs diagnosis by one of the following:
* Idiopathic lymphoid interstitial pneumonia
* Idiopathic pleuroparenchymal fibroelastosis
* Unclassifiable idiopathic interstitial pneumonias
* Chronic hypersensitivity pneumonitis
* Occupational lung disease
* Have been using oxygen therapy by nasal cannula for at least 4 weeks
* 6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits
* World Health Organization (WHO) Functional Class II-IV
* Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period
* Age between 18 and 85 years (inclusive)
Exclusion Criteria:
* Pregnant or breastfeeding females at Screening
* In the last 6 mont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.