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Acute Effects of Oxygen Supplementation Among IPF Patients

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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 -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

George Papanicolaou Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Aikaterini Markopoulou, MD, PhD
Principal Investigator Affiliation "G. Papanikolaou" General Hospital, Thessaloniki, Greece
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Greece

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions


Active Comparator: IPF patients

Supplementation of oxygen treatment (40% FiO2) during steady state cardiopulmonary exercise testing

Sham Comparator: IPF patients (crossover)

Supplementation of medical air (sham Oxygen) during steady state cardiopulmonary exercise testing


Drug: - Oxygen 40 %

Oxygen supplementation (40%) via Venturi mask

Drug: - Medical air (sham O2)

Medical air supplementation via Venturi mask

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

"G. Papanikolaou" General Hospital, Thessaloníki, Greece




"G. Papanikolaou" General Hospital

Thessaloníki, , 57010

Site Contact

Afroditi Boutou, MD, MSc, PhD