Printed from Voxsanity (voxsanity.com.au) — NCT05364957 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Obesity Trial, Recruiting
NCT05364957
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults between 18 and 65 years old, of any gender
- People who have been diagnosed with asthma according to recognised international guidelines
- People whose asthma is not well controlled (based on a specific asthma control score) even while using inhaled steroid medicines, with or without long-acting reliever inhalers
- People with grade I obesity (a body mass index, or BMI, between 30 and 35) or a higher level of obesity (BMI between 35 and 40, or below 40 with serious health risks), where bariatric (weight-loss) surgery is either not medically suitable or has been declined
- Women of childbearing age who are using effective contraception
- People who have signed a written consent form agreeing to take part
- People who have health insurance coverage
- People who have completed a full COVID-19 vaccination schedule as required by current guidelines
Who may not be able to join:
- People who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD), a separate long-term lung condition
- People with a higher-than-normal level of a specific type of white blood cell (eosinophils) in their blood
- People who have been treated with a type of medicine called biotherapy within the 12 months before joining the trial
- People who have been diagnosed with cancer within the last 5 years
- People who have smoked more than 10 packs of cigarettes per year over their lifetime
- People who have had a serious asthma attack in the 4 weeks before joining the trial
- People currently taking the weight-loss medicine orlistat (Xénical®), GLP-1 medicines (a type of diabetes/weight medicine), or who regularly use illicit drugs such as heroin, cocaine, or amphetamines (note: pain relief medicines, including strong ones, are permitted during the study)
- People for whom a swallowable intragastric balloon (a device placed in the stomach to aid weight loss) is not considered safe, including those with any of the following:
- Severe cognitive or psychiatric conditions, long-term alcoholism, or drug dependency
- Severe and unstable eating disorders such as active bulimia, or a history of anorexia
- A history of stomach surgery, including gastric band placement
- Bleeding or clotting disorders
- Current use of blood-thinning or anti-inflammatory medicines
- Severe liver disease
- Pregnancy, a desire to become pregnant, or currently breastfeeding
- Anticipated difficulty in attending required medical follow-up appointments
- Large hiatal hernias (greater than 5 cm), Crohn's disease, narrowing of the small bowel or stomach outlet, or other structural problems of the digestive tract
- Systemic lupus erythematosus (an autoimmune condition)
- Severe inflammation of the oesophagus (food pipe) or an active stomach or small intestine ulcer
- Allergy to silicone
- People who are under legal guardianship or protection, or who are currently participating in another research trial that has an exclusion period still in effect
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
Contact this trial
Principal Investigator: Guilleminault M Laurent, MD, Study principal Investigator Toulouse University Hospital
Phone: 05 67 77 18 50
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
12 May 2023
Est. completion
1 July 2029
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Asthma Control Survey
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.