Obesity Clinical Trial - Intragastric Balloon in Obese Patients With

Status Not yet recruiting

Clinical Trial Summary

The main reason of this project is to study the effect of an intagastric balloon (IGB) on obese patients with asthma, so this project aims to evaluate if an IGB associated with dietary and exercise intervention improves asthma control at 1 year in obese patients with uncotrolled asthma compared to patients with only dietary and exercise intervention.

Clinical Trial 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 normal weight, obese patients with asthma arme 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 tratment for asthma. Improved therapeutic stategies are required for obese patients with uncontrolled asthma. This project aims to evaluate if an intragastric balloon (IGB) associated with dietary and exercise intervention improves asthma control at 1 year in obese patients with uncontrolled asthma compared to patients with only dietary and exercise intervention. This IGB is an inflatable medical device that is temporarily placed in the stomach to reduce weight. It is widely used in obese patients in our estabishment, but no asthma-related data are available. In this multicenter, randomized, controlled, open-label study, obese patients with uncontrolled asthma will be recruited from the respiratory departements of four hospital centres. 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. Due to the specific management of the IGB, the research project will take the form of an open-label study. IGB procedure will be carried out in each of the investigation site, a training would be performed to homogenize the process. A follow-up period of 12 will be organised. The balloon will then be removed in the same institution with further 12-month follow-up period post-removal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05364957
Study type	Interventional
Source	University Hospital, Toulouse
Contact	Guilleminault Laurent, MD
Phone	05 67 77 18 50
Email	[email protected]
Status	Not yet recruiting
Phase	N/A
Start date	June 2022
Completion date	July 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Intragastric Balloon in Obese Patients With Uncontrolled Asthma — BOA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms