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RECRUITING
NCT05364957
NA

Intragastric Balloon in Obese Patients With Uncontrolled Asthma

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2023-05-12

Completion Date

2029-08

Last Updated

2025-12-31

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

University Hospital Toulouse

Toulouse, Occitanie, France