Status:
RECRUITING
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Obesity
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
Asthma and obesity are two major public health problems worldwide. It is now well established that there is a strong link between obesity and asthma. Management of obese patients with asthma is comple...
Eligibility Criteria
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
- 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 \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]:
- 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
- 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
Key Trial Info
Start Date :
May 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05364957
Start Date
May 12 2023
End Date
August 1 2029
Last Update
December 31 2025
Active Locations (1)
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1
University Hospital Toulouse
Toulouse, Occitanie, France, 31000