AuthorisedPhase III and phase IV (Integrated)Interventional

Impact of oxygen therapy in exertion in physical activity of patients with fibrotic intertitial lung disease with exertional hypoxemia (AFOX study)

The AFOX study is investigating if giving extra oxygen can help people with fibrotic interstitial lung disease who feel breathless when they are active. This condition causes scarring in the lungs, making it harder to breathe, especially during exercise. Researchers want to find out if using oxygen therapy can improve how many steps people take each day, helping them stay more active. They are also looking at whether oxygen helps reduce shortness of breath, improves their quality of life, and lessens feelings of anxiety and depression. The study will compare those using oxygen with a group not using it to see if there are significant improvements.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

Start

24 May 2024

Fibrotic interstitial lung disease

What is this study about?

This study, called the AFOX study, is looking into how oxygen therapy might help people living with fibrotic interstitial lung disease. This is a condition where the lungs become scarred and stiff, making it difficult to breathe, especially when you're moving around or exercising. When your body works harder, it needs more oxygen, and for some people with this condition, they don't get enough, which can make them feel very breathless. This study aims to see if giving these individuals extra oxygen can make a real difference in their daily lives.

The main thing researchers want to find out is whether using oxygen helps people walk more steps each day. Being able to move more can significantly improve a person's independence and overall wellbeing. They will compare a group of people using oxygen with a group who aren't, to understand the benefits.

Beyond just steps, the study also wants to understand how oxygen might affect other important aspects of life. This includes reducing feelings of shortness of breath, improving overall quality of life, and lessening worries or low moods often associated with long-term health conditions. They will also check if people use their oxygen as prescribed and look at body changes at a very tiny level related to stress in the body.

Key takeaways

The AFOX study investigates if oxygen helps people with fibrotic lung disease walk more.
It aims to improve breathing, quality of life, and mood for active individuals.
Participants will be split into groups, with or without oxygen, to compare results.
The study measures daily steps, breathlessness, wellbeing, and anxiety.
All adults with exertional hypoxemia due to fibrotic lung disease may be eligible.

Who may be eligible?

Anyone with fibrotic interstitial lung disease who experiences low oxygen levels when they are active might be able to join this study. Both men and women are welcome.

There are no specific age limits; adults of all ages can be considered. The doctors and nurses running the study will check your medical history to make sure it's safe and appropriate for you to participate.

Quick self-check

Do I have fibrotic interstitial lung disease?
Do I get breathless or have low oxygen levels when I am active?
Am I open to tracking my daily steps and completing surveys?
Am I able to attend regular study appointments?
Am I an adult?
Have I discussed this study with my doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it would involve being assigned to either a group that receives oxygen therapy or a group that doesn't (the control group). You would be asked to track how many steps you take each day. You would also complete questionnaires about your breathing, how you feel day-to-day, and your mood to see how the treatment affects you. There will be regular check-ups to monitor your health and how well you are using the oxygen, if you are in that group. The total length of your involvement in the study will be decided by the research team, but it will involve multiple visits and assessments over time.

Potential risks and benefits

Participating in this study could potentially offer benefits, such as receiving oxygen therapy that might improve your breathing and activity levels, or receiving close medical monitoring as part of the research. However, there might also be risks associated with any medical treatment or study, which the research team will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is fibrotic interstitial lung disease?

It's a condition where scarring develops in the lungs, making them stiff and harder to breathe, especially during activity.

What does 'exertional hypoxemia' mean?

It means your body's oxygen levels drop when you do physical activities, making you feel breathless.

What will I have to do if I join the study?

You'll be asked to track your daily steps and complete questionnaires about your breathing and feelings, plus attend regular check-ups.

Will I definitely get oxygen therapy in this study?

Not necessarily. Participants will be divided into two groups: one receiving oxygen therapy and one control group, to compare the effects.

How long will the study last?

The study involves multiple visits and assessments over a period decided by the research team. They will inform you of the exact duration.