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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
NCT05052229 |
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Date of registration:
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02/09/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF).
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Scientific title:
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Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise Intolerance |
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Date of first enrolment:
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April 21, 2022 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05052229 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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Denis E O'Donnell, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Principal Investigator, Professor |
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Name:
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Denis E O'Donnell, MD |
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Address:
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Telephone:
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6135482339 |
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Email:
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RIU@queensu.ca |
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Affiliation:
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Name:
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Devin Phillips, Ph.D. |
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Address:
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Telephone:
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6135496666 |
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Email:
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RIU@queensu.ca |
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Affiliation:
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Key inclusion & exclusion criteria
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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).
Age minimum:
40 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Medical air
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Drug: Nitric Oxide
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Primary Outcome(s)
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Inspiratory Neural Drive (IND) as measured by Diaphragmatic electromyography (EMGdi)
[Time Frame: During exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).]
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Ventilatory efficiency (VE/VCO2)
[Time Frame: During exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).]
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Secondary Outcome(s)
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Dyspnea Intensity
[Time Frame: During exercise test on visit 4 and 5, every 1 minute, through end-exercise (average time 6-10minutes).]
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Secondary ID(s)
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BI 1199.0477
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DMED 2495-21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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