Clinical trial NCT05364957: Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Official title: Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Asthma
Keywords: Intra Gastric Balloon
uncontrolled asthma
Obesity with asthma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly assigned either to the group treated with IGB combined with diet and exercise or the group treated with diet and exercise alone.
Primary purpose: TREATMENT

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 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.

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 complex in clinical practice because, compared to asthma patients with a normal weight, obese patients with asthma are more prone to respiratory symptoms, asthma attacks and hospital admissions. Lower sensitivity to asthma treatments has also been observed. Indeed, obese patients with moderate to severe asthma respond less well to inhaled corticosteroids, which constitute the recommended treatment for asthma. Improved therapeutic strategies are required for obese patients with uncontrolled asthma.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Asthma Control Survey
timeFrame: 12 months
Secondary outcomes:
measure: Asthma control
timeFrame: 6 months, 18 months and 24 months
measure: Weight loss
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: The number of patients with an Asthma Control Questionnaire score ≤ 1
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: The change of exacerbations
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: The change of hospital admissions or emergency visits for asthma exacerbation
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: Inhaled corticosteroids daily dose
timeFrame: 6 months, 12 months, 18 months, 24 months.
measure: Forced expiratory volume in 1 second
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: vital capacity
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: Total lung capacity
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: Asthma quality
timeFrame: 6 months, 12 months, 18 months and 24 months
Other outcomes:
measure: Physical activity
timeFrame: 6 months, 12 months, 18 months and 24 months
measure: Immunoglobulin E (IgE) repertoire of B-lymphocytes
timeFrame: 12 months
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
state: Occitanie
Study officials:
affiliation: Study principal Investigator Toulouse University Hospital
name: Guilleminault M Laurent, MD
role: PRINCIPAL_INVESTIGATOR
References: