RecruitingNAINTERVENTIONAL

Intragastric Balloon in Obese Patients With Uncontrolled Asthma

This research aims to understand if a special temporary device placed in the stomach, called an intragastric balloon (IGB), can help people with both obesity and asthma to breathe better. Many people with obesity find their asthma harder to control and their usual medicines don't work as well. This study will involve people aged 18-65 who have obesity and asthma that isn't well-controlled. Participants will be split into two groups: one receiving the balloon along with diet and exercise advice, and the other receiving only diet and exercise advice. We will compare these groups after one year to see if the balloon helps improve asthma symptoms more effectively.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

12 May 2023

Estimated completion

01 Aug 2029

Obesity Asthma

What is this study about?

Asthma and obesity are both common health issues. It's becoming clearer that there's a strong link between them. If you have obesity and asthma, you might find your breathing problems are worse, you have more asthma attacks, and you might even need to go to hospital more often. Plus, for many people, the usual asthma medications don't seem to work as well when they also have obesity.

This makes managing asthma quite complicated for people with obesity. Doctors and researchers are looking for better ways to help. This study is exploring a new approach involving a temporary device placed in the stomach, called an intragastric balloon (IGB). This balloon can help people feel fuller and eat less, leading to weight loss.

The main goal of this research is to see if using an intragastric balloon alongside diet and exercise advice can improve asthma control more than just diet and exercise alone. By taking part, you could help us understand how to better support people who have both these conditions, potentially leading to new ways to improve their health and quality of life.

Key takeaways

Looks at how an intragastric balloon might improve asthma in people with obesity.
Compares the balloon (plus diet/exercise) to diet and exercise alone.
Aims to find better ways to manage asthma when obesity is also present.
Participants must have uncontrolled asthma and obesity (BMI 30-40).
Study lasts for one year with regular check-ups.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old. You must have asthma that isn't well-controlled, even with your current inhalers. You also need to have obesity (a BMI between 30 and 40), and either not be able to have weight-loss surgery or have chosen not to. For women, effective contraception is required, and everyone needs to have signed a consent form and have health insurance. You must also have your COVID-19 vaccinations up to date.

There are certain reasons you wouldn't be able to join. For instance, if you have a different lung disease called COPD, or certain blood conditions. If you've had cancer in the last five years, or if you smoke more than 10 packs of cigarettes a year (which is roughly smoking a pack a day for 10 years), you can't take part. You also can't have had a severe asthma flare-up in the month before joining or before the balloon is fitted.

Additionally, there are specific health conditions that would prevent you from having an intragastric balloon. These include severe mental health issues, alcohol or drug addiction, severe eating disorders, previous stomach surgery, certain bleeding disorders, serious liver disease, or if you are pregnant, planning to become pregnant, or breastfeeding. If you have a large hiatus hernia or inflammatory bowel disease, or if it's thought you might struggle to attend all follow-up appointments, you also can't participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have asthma that isn't well-controlled, even with your inhalers?
Do you have obesity (BMI between 30 and 40)?
Have you had your COVID-19 vaccinations?
Are you able to attend all follow-up appointments?
Are you *not* pregnant, breastfeeding, or planning a pregnancy soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive an intragastric balloon, plus advice on diet and exercise. The other group will receive only diet and exercise advice. You won't know which group you're in until after you've joined. The intragastric balloon is a temporary device that stays in your stomach for a period of time, usually removed after about six months.

During the study, you'll have regular check-ups to monitor your progress and asthma control. We'll use a special questionnaire (called an ACQ) to track changes in your asthma. The study aims to look at your health over a full year, comparing how your asthma control changes from the beginning to the end of that year, depending on which group you were in.

Potential risks and benefits

Participating in this study might offer you the benefit of better asthma control and improved overall health, especially if the intragastric balloon proves to be an effective treatment. However, like any medical procedure, the intragastric balloon has potential risks, including discomfort or complications, which your doctor will discuss with you. You will receive advice on diet and exercise, which can be beneficial to your health regardless of which group you are in. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is an intragastric balloon?

It's a soft, temporary device placed in your stomach to help you feel full and eat less, which can lead to weight loss.

Will I know if I get the balloon or not?

You will be assigned to a group randomly, like drawing lots, and you'll be told which group you're in once you've joined.

How long will the study last?

The main part of the study will involve monitoring your health and asthma over a period of one year.

What is 'uncontrolled asthma'?

This means your asthma symptoms are still causing problems, even though you're using your usual inhalers and medicines.

Is the intragastric balloon permanent?

No, it's a temporary device and is usually removed after about six months.

How to find out more

Guilleminault Laurent, MD

guilleminault.l@chu-toulouse.fr 05 67 77 18 50 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.