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NCT Number: NCT03688334

Acute Effects of Oxygen Supplementation Among IPF Patients

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"G. Papanikolaou" General Hospital

Thessaloniki, 57010, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable IPF patients with no hospitalization, exacerbation or change in regular IPF medication during the last month
  • IPF patients do not present with resting hypoxemia, but manifest exercise induced hypoxemia

Exclusion criteria

  • Major contraindications for CPET conduction
  • Not provision of informed consent -

Treatment and study plan

Oxygen 40 %

Drug

Oxygen supplementation (40%) via Venturi mask

Medical air (sham O2)

Drug

Medical air supplementation via Venturi mask

Primary outcomes

  1. Exercise duration

    Time frame: through study completion, an average of a year

    Exercise duration (minutes) of steady state cardiopulmonary exercise testing until exhaustion

Secondary outcomes

  1. Dyspnea

    Time frame: through study completion, an average of a year

    maximum dyspnea assessed with modified Borg dyspnea scale (range from 0: nothing at all to 10: maximum dyspnea), during steady state cardiopulmonary exercise testing

  2. Fatigue

    Time frame: through study completion, an average of a year

    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

Other outcomes

  1. Cerebral oxygenated hemoglobin

    Time frame: through study completion, an average of a year

    The minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing

  2. Cardiac output

    Time frame: through study completion, an average of a year

    The maximum value of cardiac output in L/min during steady state cardiopulmonary exercise testing

Sponsors and collaborators

Lead sponsor

George Papanicolaou Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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