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INOpulse for Pulmonary Hypertension with Pulmonary Fibrosis
Study Summary
This trial studies the safety and effectiveness of a drug to help with breathing problems in people with pulmonary fibrosis using oxygen therapy.
- Pulmonary Fibrosis
- Pulmonary Hypertension
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with World Health Organization (WHO) Functional Class II-IV.In the last 6 months before the screening, you have a connective tissue disease that affects your lungs, unless a CT scan shows moderate to severe fibrosis.Your lung function was measured and it needs to be at least 40% of what is expected for someone your age and size.You must be between 18 and 85 years old.You have been diagnosed with pulmonary fibrosis within the last 6 months using specific guidelines and tests.You have been using a nasal cannula for oxygen therapy for at least 4 weeks.You need to be able to walk between 100 and 450 meters in six minutes during screening and baseline visits.
- Group 1: Placebo
- Group 2: Long Term Follow Up
- Group 3: Inhaled Nitric Oxide (iNO)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is eligible to participate in this experimental study?
"Patients with pulmonary fibrosis aged between 18 and 85 may apply to be selected as part of this trial. In total, the study is hoping to recruit eighty-five individuals."
Does this medical study accept individuals aged sixty or more?
"This trial is seeking qualified applicants aged 18 to 85, while other research initiatives are targeting patients younger than 18 (127 trials) and those older than 65 (1038 studies)."
Has the recruitment for this study been opened to new participants?
"As recorded on clinicaltrials.gov, this trial is not currently enrolling patients. The project was initially posted in December 2017 and last updated in February 2023; however, there are still 1153 other studies actively looking for participants."
How many sites have been selected to host this research endeavor?
"23 institutions are offering this clinical trial, the University of California in Los Angeles, University of California Davis Health in Sacramento and University of Colorado Hospital in Aurora being some examples."
What risks are associated with the inhalation of Nitric Oxide (iNO)?
"Due to the Phase 2 status of Inhaled Nitric Oxide (iNO), there is some data confirming its safety, leading it to be assigned a score of 2. However, no evidence exists yet that supports efficacy."
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