Informations générales (source: ClinicalTrials.gov)
Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study (BOA)
Interventional
N/A
University Hospital, Toulouse (Voir sur ClinicalTrials)
mai 2023
août 2027
18 juillet 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | AMEL BOUDJEMAA | 26/02/2025 10:18:35 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| University Hospital Toulouse - 31000 - Toulouse - Occitanie - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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