Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
University Hospital, Toulouse
84 participants
May 12, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria10
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Blood eosinophilia greater than 4.5 G/I
- Treatment by biotherapy within the 12 months after inclusion
- Cancer diagnosed within the last 5 years
- Smoking \> 10 packs/year (PA)
- One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement.
- 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.
- Any patient for whom IGB is contraindicated \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]:
- 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
- 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
Interventions
Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).
Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.
Locations(1)
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NCT05364957