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.
• 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