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Vasodilator

Inhaled Nitric Oxide for Idiopathic Pulmonary Fibrosis

Q: Does this experiment still have openings for participants?

Affirmative. Clinicaltrials.gov provides evidence that this test is presently looking for 40 participants at a single location, with the initial posting taking place on April 21st 2022 and most recent updated occurring on the same date.

Q: Has research involving Nitric Oxide been previously conducted?

At present, there are 23 active trials for Nitric Oxide. Of those, 8 are in their final Phase 3 stage of testing. While the focus is on Shreveport <a href="https://www.withpower.com/clinical-trials/louisiana">Louisiana</a>, 99 clinics across America have signed up to participate in these studies.

Q: How many participants are currently participating in this medical trial?

Affirmative. The clinicaltrials.gov listing for this trial confirms that it is actively enrolling participants, having been posted on April 21st 2022 and last amended the same day. At present, 40 people are needed to be enrolled from a single site.

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)

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).

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inspiratory Neural Drive (IND) as measured by Diaphragmatic electromyography (EMGdi)

Ventilatory efficiency (VE/VCO2)

Secondary outcome measures

Dyspnea Intensity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nitric OxideActive Control1 Intervention

Inhaled 40 ppm nitric oxide from a KINOX gas cylinder system (Air Liquid Healthcare, Montreal, Quebec, Canada; DIN 02451328).

Group II: PlaceboPlacebo Group1 Intervention

Inhaled medical grade normoxic gas (FiO2 = 0.21; DIN 02238755 Air Liquide Healthcare, Montreal, Quebec, Canada).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dr. Denis O'DonnellLead Sponsor

6 Previous Clinical Trials

197 Total Patients Enrolled

Queen's UniversityLead Sponsor

365 Previous Clinical Trials

120,377 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,832 Total Patients Enrolled

49 Trials studying Idiopathic Pulmonary Fibrosis

45,341 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT05052229 — Phase < 1

Idiopathic Pulmonary Fibrosis Research Study Groups: Placebo, Nitric Oxide

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Nitric Oxide Highlights & Side Effects. Trial Name: NCT05052229 — Phase < 1

Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05052229 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment still have openings for participants?

"Affirmative. Clinicaltrials.gov provides evidence that this test is presently looking for 40 participants at a single location, with the initial posting taking place on April 21st 2022 and most recent updated occurring on the same date."

Answered by AI

Has research involving Nitric Oxide been previously conducted?

"At present, there are 23 active trials for Nitric Oxide. Of those, 8 are in their final Phase 3 stage of testing. While the focus is on Shreveport Louisiana, 99 clinics across America have signed up to participate in these studies."

Answered by AI

How many participants are currently participating in this medical trial?

"Affirmative. The clinicaltrials.gov listing for this trial confirms that it is actively enrolling participants, having been posted on April 21st 2022 and last amended the same day. At present, 40 people are needed to be enrolled from a single site."

Answered by AI