Inhaled nitric oxide for improving exercise capacity in patients with idiopathic pulmonary fibrosis.
Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise Intolerance
This study is testing if inhaled nitric oxide can help people with mild idiopathic pulmonary fibrosis breathe better during exercise compared to a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT05052229 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of inhaled nitric oxide (iNO) on ventilatory efficiency and inspiratory neural drive in patients with mild idiopathic pulmonary fibrosis (IPF). It aims to compare these effects against a placebo during a cardiopulmonary exercise test. The study will recruit 20 patients with diagnosed mild IPF and 20 healthy controls to assess the potential benefits of iNO in alleviating exertional dyspnea. The research is conducted at the Respiratory Investigation Unit of Kingston General Hospital.
Who should consider this trial
Good fit: Ideal candidates are clinically stable adults over 40 years old with a diagnosis of mild idiopathic pulmonary fibrosis.
Not a fit: Patients with significant emphysema, airway obstruction, or other active cardiopulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance exercise capacity and reduce breathlessness in patients with idiopathic pulmonary fibrosis.
How similar studies have performed: While the use of inhaled nitric oxide has been explored in various contexts, this specific application in mild IPF is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * clinically stable, as defined by stable hemodynamic status, optimized medical treatment, no changes in medication dosage or frequency of administration with no hospital admissions in the preceding 6 weeks; * Mild or absent mechanical restriction as determined by a total lung capacity (TLC) \>70% predicted; * male or female non-pregnant adults \>40 years of age; * ability to perform all study procedures and provide informed consent. * A key IPF inclusion criterion includes, in addition to the above, a clinical diagnosis of idiopathic pulmonary fibrosis. Exclusion criteria: * women of childbearing potential who are pregnant or trying to become pregnant; * computed tomography evidence of any (significant) emphysema * evidence of airway obstruction (forced expiratory volume in 1 s/forced vital capacity \<0.70, * active cardiopulmonary disease (other than IPF) or other comorbidities that could contribute to dyspnea and exercise limitation; * history/clinical evidence of asthma, atopy and/or nasal polyps; * currently taking phosphodiesterase type 5 inhibitors; * important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s); * body mass index (BMI) \<18.5 or ≥35.0 kg/m2; * use of daytime oxygen or exercise-induced O2 desaturation (\<80% on room air).
Where this trial is running
Kingston, Ontario
- Respiratory Investigation Unit, Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Denis E O'Donnell, MD — Principal Investigator, Professor
- Study coordinator: Devin Phillips, Ph.D.
- Email: RIU@queensu.ca
- Phone: 6135496666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.