Tests a stomach balloon for asthma in adults with obesity
Tests a gastric balloon with diet and exercise in adults with obesity and uncontrolled asthma.
Plain-language title generated from the registry record
Registry title: Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Key facts
- Where
- Toulouse, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05364957, who can take part
Where in France
- University Hospital, ToulouseToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT05364957
- Record updated
- 31 December 2025
- Original description
The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.Read full original descriptionShow less
Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.
Inclusion: Men and women aged between 18 and 65 years; Asthma according to the Global Initiative for Asthma (GINA) criteria; Patients with uncontrolled asthma based on an ACQ score ≥1.5 despite inhaled corticosteroids ± long acting bronchodilators (LABA); 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; Effective contraception for women; Patients who have signed a written informed consent form; Patients with health insurance; Complete COVID-19 vaccination schedule according to current guidelines.
Exclusion: 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; Diagnosis of Chronic Obstructive Pulmonary Disease (COPD); Cancer diagnosed within the last 5 years; 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; Blood eosinophilia greater than 4.5 G/I; Treatment by biotherapy within the 12 months after inclusion; Smoking > 10 packs/year (PA); One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement; 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.