Inhaled Nitric Oxide for Idiopathic Pulmonary Fibrosis

Phase < 1

Recruiting

Led By Denis E O'Donnell, MD

Research Sponsored by Dr. Denis O'Donnell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A key IPF inclusion criterion includes, in addition to the above, a clinical diagnosis of idiopathic pulmonary fibrosis

Clinical diagnosis of idiopathic pulmonary fibrosis (for key IPF inclusion criterion)

Must not have

Important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s)

Women of childbearing potential who are pregnant or trying to become pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).

Summary

This trial is examining whether inhaled nitric oxide can help with symptoms of idiopathic pulmonary fibrosis, a progressive lung disease.

Who is the study for?

Adults over 40 with a clinical diagnosis of mild Idiopathic Pulmonary Fibrosis (IPF) and no recent hospital admissions can join this trial. They must have minimal lung restriction, be clinically stable, able to perform study tasks, and not pregnant. Exclusions include significant emphysema, active heart/lung diseases other than IPF, severe obesity or underweight conditions, certain medication use, and exercise limitations due to neuromuscular issues.

What is being tested?

The trial is testing the effects of inhaled nitric oxide (iNO) versus medical air placebo on breathing efficiency during rest and exercise in IPF patients compared to healthy controls. Participants will undergo several visits including pulmonary function tests, CT scans, chemoreceptor sensitivity assessments, familiarization exercises sessions followed by two blinded test sessions with either iNO or placebo.

What are the potential side effects?

Inhaled Nitric Oxide may cause side effects such as headache, dizziness or fainting spells due to changes in blood pressure; it might also lead to respiratory tract irritation if used frequently at high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with idiopathic pulmonary fibrosis.

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I have been diagnosed with idiopathic pulmonary fibrosis.

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My lung function is mostly normal.

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My health condition has been stable, with no hospital visits or medication changes in the last 6 weeks.

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I am over 40 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot exercise due to nerve or muscle diseases.

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I am a woman who could become pregnant and am either pregnant or trying to conceive.

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I have heart or lung conditions that make it hard for me to breathe or exercise.

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I am currently taking medication for erectile dysfunction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).

This trial's timeline: 3 weeks for screening, Varies for treatment, and during exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes). for reporting.