Acute Effects of Oxygen Supplementation Among IPF Patients

Study Overview
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Brief Summary
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Idiopathic pulmonary fibrosis (IPF) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with IPF, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial. Based on the aforementioned, the purpose of this prospective, cross-over clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with IPF, without resting hypoxemia, during steady state cardiopulmonary exercise testing (CPET).

Official Title
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Acute Effects of Oxygen Supplementation During Exercise Among Patients With Idiopathic Pulmonary Fibrosis Without Resting Hypoxemia

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Oxygen 40 %
* Drug: Medical air (sham O2)


Participation Criteria
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Eligibility 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: Major contraindications for CPET conduction Not provision of informed consent -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPF patients<br>Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing | Drug: Oxygen 40 %<br>* Oxygen supplementation (40%) via Venturi mask<br>|
| Sham Comparator: IPF patients (crossover)<br>Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing | Drug: Medical air (sham O2)<br>* Medical air supplementation via Venturi mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise duration | Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion | through study completion, an average of a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing | through study completion, an average of a year | 
| Fatigue | maximum fatigue assessed by Borg's Rating of Perceived Exertion Scale (range from 6: no exertion to 20: maximal exertion), during steady state cardiopulmonary exercise testing | through study completion, an average of a year |