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Study on the Effects of High-Flow Oxygen Therapy in Patients with Interstitial Lung Disease During Exercise

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with Diffuse Interstitial Lung Disease (ILD), a condition that affects the lungs and can cause difficulty in breathing. The study aims to explore whether using high-flow oxygen can improve oxygen levels during exercise, which is an important part of pulmonary rehabilitation for these patients. The treatment being studied involves two types of oxygen therapy: conventional oxygen therapy using a nasal cannula and high-flow oxygen systems. The main goal is to compare how well each method helps maintain oxygen levels during muscle training exercises.

Participants in the study will undergo a series of exercises as part of their rehabilitation program. During these exercises, their oxygen levels will be monitored to see which method provides better oxygenation. The study will also look at other aspects such as how breathlessness affects daily activities and exercise capacity, as well as overall quality of life. These will be assessed using various questionnaires and tests, including the 6-minute walk test, which measures how far a person can walk in six minutes.

The study will last for a period of time, during which participants will receive either the conventional or high-flow oxygen therapy. The results will help determine if high-flow oxygen can offer additional benefits over the standard method. This information could be valuable in improving treatment strategies for patients with ILD who experience oxygen desaturation, or low oxygen levels, during physical activity.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the informed consent form is signed. This confirms understanding and agreement to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This includes a full pulmonary function test which measures lung capacity and function.

    You will also complete questionnaires to assess your health-related quality of life and any breathing difficulties you experience during daily activities.

  3. Step 3

    Exercise training

    Participate in a pulmonary rehabilitation program designed to improve lung function and exercise capacity. This involves muscle training exercises.

    During the training, you will receive oxygen through either a nasal cannula or a high-flow oxygen system to compare their effectiveness in maintaining oxygen levels.

  4. Step 4

    Oxygen administration

    The oxygen used in the study is Conoxia 100% medicinal gas, administered as an inhalation gas. The dosage and frequency will be determined by the study team based on your needs during exercise.

  5. Step 5

    Ongoing monitoring

    Throughout the study, your oxygen saturation levels will be monitored to ensure safety and effectiveness of the treatment.

    You will be asked to report any adverse effects or events you experience during the program.

  6. Step 6

    Final assessment

    At the end of the study, a final assessment will be conducted to evaluate changes in your lung function and exercise capacity.

    You will complete the same questionnaires as in the initial assessment to measure any improvements in your quality of life and breathing difficulties.

Who can join the trial?

3 criteria

  • Age must be over 30 years.
  • Must have a diagnosis of Interstitial Lung Disease (ILD), which is a group of lung disorders, according to national and international guidelines.
  • Must have signed an informed consent form, which means you agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients with a history of ILD (Interstitial Lung Disease) cannot participate. This is a condition where the lungs become scarred and breathing becomes difficult.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible.
  • Patients who do not meet the specific health criteria set by the study cannot participate. These criteria are designed to ensure the safety and effectiveness of the study.
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Investigated drugs

  • Conventional Oxygen Therapy

    is a treatment that provides extra oxygen to people who have trouble getting enough oxygen on their own. In this trial, it is delivered through a nasal cannula, which is a small, flexible tube that sits under the nose. This therapy helps improve oxygen levels in the blood, making it easier for patients to breathe, especially during physical activities.

  • High-Flow Oxygen Therapy

    is a more advanced way of delivering oxygen to patients. It uses a special machine to provide a higher flow of oxygen than conventional methods. This therapy can deliver warm and humidified oxygen, which can be more comfortable for patients. In this trial, it is used to see if it can better maintain oxygen levels during exercise for patients with lung disease.

What is already known about the treatment

High-flow oxygen therapy – High-flow oxygen therapy is administered through a special device that delivers a high flow of oxygen through a nasal cannula. It is currently being studied in clinical trials to assess its effectiveness in improving oxygenation during exercise for patients with Diffuse Interstitial Lung Disease (ILD) who experience oxygen desaturation during physical activity. The main therapeutic indication is to enhance oxygen levels in the blood during exercise, potentially optimizing the benefits of pulmonary rehabilitation. At the molecular level, it works by providing a higher concentration of oxygen, which can improve the efficiency of oxygen uptake in the lungs. It is classified as a respiratory support therapy.

Investigated diseases

Interstitial Lung Disease (ILD) – Interstitial Lung Disease refers to a group of disorders that cause progressive scarring of lung tissue. This scarring affects the interstitium, which is the tissue and space around the air sacs of the lungs. As the disease progresses, the lung tissue becomes thickened and stiff, leading to difficulty in breathing and reduced oxygen transfer to the bloodstream. Over time, the scarring can worsen, making it increasingly difficult for the lungs to function properly. The progression of ILD can vary significantly among individuals, with some experiencing rapid deterioration and others having a slower course. The exact cause of the scarring can be difficult to determine, and it may result from long-term exposure to hazardous materials, certain medications, or autoimmune diseases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519541-30-00Protocol codeIIBSP-OXI-2017-18Estimated enrolment60 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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