Could a stomach balloon tame uncontrolled asthma in obese patients?
NCT ID NCT05364957
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether placing a temporary intragastric balloon (a soft balloon in the stomach) along with diet and exercise can improve asthma control in obese people whose asthma is not well managed by inhalers. About 84 participants will be randomly assigned to get the balloon plus lifestyle changes or lifestyle changes alone. The main goal is to see if asthma control scores improve after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intragastric balloon device
- What this could lead to
- If it works, this could offer a new way to improve asthma control in obese patients who have not responded to standard treatments.
- What could go wrong
- This is a relatively small, early-stage study (84 participants) and the balloon is a temporary device with risks like discomfort or complications. The improvement in asthma may be modest or not sustained long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women aged between 18 and 65 years 2. Asthma according to the Global Initiative for Asthma (GINA) criteria 3. Patients with uncontrolled asthma based on an ACQ score ≥1.5 despite inhaled corticosteroids ± long acting bronchodilators (LABA) 4. Patients with grade I obesity (BMI\> 30 kg/m² and \< 35 kg/m²) or morbid obesity (BMI\<40 or ≥35 kg/m² with serious physiological risks, as recommended by the French Health Authorities) with contraindications for or refusal of bariatric surgery. 5. Effective contraception for women 6. Patients who have signed a written informed consent form 7. Patients with health insurance 8. Complete COVID-19 vaccination schedule according to current guidelines Exclusion Criteria: 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Blood eosinophilia greater than 4.5 G/I 3. Treatment by biotherapy within the 12 months after inclusion 4. Cancer diagnosed within the last 5 years 5. Smoking \> 10 packs/year (PA) 6. One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement. 7. Treatment with orlistat Xénical® or GLP1 analogues or regular consumption of narcotics (heroin, cocaine and amphetamines). Analgesic treatments, including level 3, are authorized during the study. 8. Any patient for whom IGB is contraindicated \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]: 8.1 Severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction 8.2 Severe and unstabilised eating disorders: bulimia or history of anorexia 8.3 History of gastric surgery including the ring insertion 8.4 Haemostasis disorders 8.5 Anticoagulant or non-steroidal anti-inflammatory medicines 8.6 Severe liver disease 8.7 Pregnancy or desire to become pregnant or breastfeeding 8.8 Anticipated failure to comply with prolonged medical follow-up 8.9 Large hiatal hernias \> 5 cm, inflammatory (Crohn's) or stenosing small bowel disease, pyloric stenosis and structural abnormalities of the digestive tract 8.10 Systemic lupus erythematous 8.11 Severe oesophagitis and active gastroduodenal ulcer 8.12 Silicone allergy 9. Patient under guardianship or tutorship, persons placed under the protection of justice or persons participating in another search including an exclusion period still in progress
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Toulouse
RECRUITINGToulouse, Occitanie, 31000, France
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