Intragastric Balloon in Obese Patients With Uncontrolled Asthma (BOA)

Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Device: Intragastric balloon device; Procedure: Dietary; Procedure: Exercise intervention

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guilleminault Laurent, MD; Phone Number: 33 05 67 77 18 50; Email: guilleminault.l@chu-toulouse.fr

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31000
      • Recruiting
      • University Hospital TOULOUSE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control (PEC dietary hygiene); Diet and exercise alone (control)	Procedure: Dietary; The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).; Procedure: Exercise intervention; Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.
Experimental: Experimental (BIG + PEC dietary hygiene); Intragastric balloon combined with diet and exercise (active)	Device: Intragastric balloon device; Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically; Procedure: Dietary; The patient will benefit from dietary intervention that follows a standard medical recommendation; In consultation with a dietician (at M1, M4, M7, M13, M19, M25), patients will be asked to follow an appropriate diet with a balanced intake of macronutrients (55% carbohydrates, 30% lipids and 15% proteins).; Procedure: Exercise intervention; Patient will benefit from exercise intervention; Resistance and aerobic exercises will be performed twice a week for 3 months (between M4 and M7) under the supervision of a physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Survey	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control	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.	6 months, 18 months and 24 months
The number of patients with an Asthma Control Questionnaire score ≤ 1	The proportion of patients with an Asthma Control Questionnaire score ≤ 1 measured by ACQ questionnaire	6 months, 12 months, 18 months and 24 months
Inhaled corticosteroids daily dose	The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline	6 months, 12 months, 18 months, 24 months.
Forced expiratory volume in 1 second	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.	6 months, 12 months, 18 months and 24 months
vital capacity	The change of vital capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.	6 months, 12 months, 18 months and 24 months
Total lung capacity	the change of total lung capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.	6 months, 12 months, 18 months and 24 months
Asthma quality	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	6 months, 12 months, 18 months and 24 months
Weight loss	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)).	6 months, 12 months, 18 months and 24 months
The change of exacerbations	The change of exacerbations which is defined as a course of oral corticosteroids compared to the 12 months period before intervention	6 months, 12 months, 18 months and 24 months
The change of hospital admissions or emergency visits for asthma exacerbation	The change in the annual number of hospital admissions or emergency visits for asthma exacerbation compared to baseline with data collection by questionnaire.	6 months, 12 months, 18 months and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	The change of physical activity score measured by the Ricci and Gagnon Questionnaire compared to baseline. The total score is divided into 3 categories: under 18 means inactive physical activity; between 18 and 35 means active physical activity; over 35 means very active activity	6 months, 12 months, 18 months and 24 months
Immunoglobulin E (IgE) repertoire of B-lymphocytes	The change of the IgE repertoire of B-lymphocytes compared to baseline: through the gene expression signature profiling of specific IgEs of Der p 1 and Der p 2 (the two main allergens of mites) produced by B cells, using a single cell RNA sequencing technique.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Guilleminault M Laurent, MD, Study principal Investigator Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Intra Gastric Balloon; uncontrolled asthma; Obesity with asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: RC31/18/0473; 2019-A00595-52 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No