Intragastric Balloon in Obese Patients With Uncontrolled Asthma

NCT05364957 | Recruiting DMC

• 2 other identifiers: RC31/18/04732019-A00595-52
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Asthma

Keywords

Intra Gastric Balloon; uncontrolled asthma; Obesity with asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Asthma control

  6 months, 18 months and 24 months

• Weight loss

  6 months, 12 months, 18 months and 24 months

• The number of patients with an Asthma Control Questionnaire score ≤ 1

  6 months, 12 months, 18 months and 24 months

• The change of exacerbations

  6 months, 12 months, 18 months and 24 months

• The change of hospital admissions or emergency visits for asthma exacerbation

  6 months, 12 months, 18 months and 24 months

Other Outcomes (2)

• Physical activity

  6 months, 12 months, 18 months and 24 months

• Immunoglobulin E (IgE) repertoire of B-lymphocytes

  12 months

Study Arms (2)

control (PEC dietary hygiene)

OTHER

Diet and exercise alone (control)

Procedure: Dietary; Procedure: Exercise intervention

Experimental (BIG + PEC dietary hygiene)

EXPERIMENTAL

Intragastric balloon combined with diet and exercise (active)

Device: Intragastric balloon device; Procedure: Dietary; Procedure: Exercise intervention

Interventions

Dietary PROCEDURE

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).

Experimental (BIG + PEC dietary hygiene); control (PEC dietary hygiene)

Exercise intervention PROCEDURE

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 (BIG + PEC dietary hygiene); control (PEC dietary hygiene)

Intragastric balloon device DEVICE

Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically

Experimental (BIG + PEC dietary hygiene)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 recommended by the French Health Authorities) with contraindications for or refusal of bariatric surgery.
• 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

You may not qualify if:

• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Blood eosinophilia greater than 4.5 G/I
• Cancer diagnosed within the last 5 years
• Smoking \> 10 packs/year (PA)
• 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 \[criteria defined by the French Society for Digestive Endoscopy) and the French Think-Tank for Hepato-Gastroenterology Practices\]:
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Occitanie, 31000, France

RECRUITING

MeSH Terms

Conditions

Obesity; Asthma

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Guilleminault M Laurent, MD

  Study principal Investigator Toulouse University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilleminault Laurent, MD

CONTACT

05 67 77 18 50; guilleminault.l@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 6, 2022
• Study Start: May 12, 2023
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)