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New treatment option for Obesity
Official title Intragastric Balloon in Obese Patients With Uncontrolled Asthma
ClinicalTrials.gov ID: NCT05364957
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Effective contraception for women
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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
- 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]: 8.1 Severe cognitive or psychiatric...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, Occitanie, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, Occitanie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.