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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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12 December 2020 |
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Main ID: |
NCT03688334 |
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Date of registration:
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20/09/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Acute Effects of Oxygen Supplementation Among IPF Patients
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Scientific title:
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Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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15 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03688334 |
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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: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Afroditi Boutou, MD, MSc, PhD |
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Address:
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Telephone:
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00306946611433 |
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Email:
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afboutou@yahoo.com |
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Affiliation:
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Name:
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Afroditi Boutou, MD, PhD, MSc |
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Address:
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Telephone:
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00306946611433 |
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Email:
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afboutou@yahoo.com |
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Affiliation:
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Name:
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Aikaterini Markopoulou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"G. Papanikolaou" General Hospital, Thessaloniki, Greece |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Stable IPF patients with no hospitalization, exacerbation or change in regular IPF
medication during the last month, who do not present with resting hypoxemia, but manifest
exercise induced hypoxemia
Exclusion Criteria:
1. Major contraindications for CPET conduction
2. Not provision of informed consent -
Age minimum:
18 Years
Age maximum:
80 Years
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: Oxygen 40 %
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Drug: Medical air (sham O2)
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Primary Outcome(s)
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Exercise duration
[Time Frame: through study completion, an average of a year]
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Secondary Outcome(s)
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Dyspnea
[Time Frame: through study completion, an average of a year]
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Fatigue
[Time Frame: through study completion, an average of a year]
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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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