Intragastric Balloon in Obese Patients With Uncontrolled Asthma

Not Applicable

Recruiting

• Conditions: Obesity; Asthma
• Interventions: Procedure: Dietary; Device: Intragastric balloon device; Procedure: Exercise intervention

• Registration Number: NCT05364957
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2023-05-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-07
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental (BIG + PEC dietary hygiene)	Exercise intervention	Intragastric balloon combined with diet and exercise (active)
control (PEC dietary hygiene)	Dietary	Diet and exercise alone (control)
control (PEC dietary hygiene)	Exercise intervention	Diet and exercise alone (control)
Experimental (BIG + PEC dietary hygiene)	Intragastric balloon device	Intragastric balloon combined with diet and exercise (active)
Experimental (BIG + PEC dietary hygiene)	Dietary	Intragastric balloon combined with diet and exercise (active)

Primary Outcome Measures

Name	Time	Method
Asthma Control Survey	12 months	the proportion of patients with changed asthma control at 12 months , defined as a reduction in the Asthma Control Score (ACQ) ≥ 0.5, compared to baseline.

Secondary Outcome Measures

Name	Time	Method
The change of hospital admissions or emergency visits for asthma exacerbation	6 months, 12 months, 18 months and 24 months	The change in the annual number of hospital admissions or emergency visits for asthma exacerbation compared to baseline with data collection by questionnaire.
Inhaled corticosteroids daily dose	6 months, 12 months, 18 months, 24 months.	The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline
Forced expiratory volume in 1 second	6 months, 12 months, 18 months and 24 months	The change of forced expiratory volume in 1 second (FEV 1) value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.
vital capacity	6 months, 12 months, 18 months and 24 months	The change of vital capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.
Asthma quality	6 months, 12 months, 18 months and 24 months	The change of mini-Asthma Quality of Life Questionnaire score compared to baseline.The score is evaluated on 7 points, the highest score indicates a better quality of life
The number of patients with an Asthma Control Questionnaire score ≤ 1	6 months, 12 months, 18 months and 24 months	The proportion of patients with an Asthma Control Questionnaire score ≤ 1 measured by ACQ questionnaire
The change of exacerbations	6 months, 12 months, 18 months and 24 months	The change of exacerbations which is defined as a course of oral corticosteroids compared to the 12 months period before intervention
Total lung capacity	6 months, 12 months, 18 months and 24 months	the change of total lung capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.
Asthma control	6 months, 18 months and 24 months	The proportion of patients with changed asthma control at 6 months, 18 months and 24 months, defined as a reduction in the asthma control score (ACQ) ≥ 0.5 compared to baseline.
Weight loss	6 months, 12 months, 18 months and 24 months	Weight loss evaluated according to the percentage weight loss from baseline to post-procedure (\[weight before (in kg) - weight after (in kg)\] / weight before (in kg)).

Trial Locations

Locations (1)

University Hospital Toulouse; 🇫🇷 Toulouse, Occitanie, France