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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
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).
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.
University Hospital Toulouse
Toulouse, Occitanie, France
RECRUITINGAsthma 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.
Time frame: 12 months
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.
Time frame: 6 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)).
Time frame: 6 months, 12 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
Time frame: 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
Time frame: 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.
Time frame: 6 months, 12 months, 18 months and 24 months
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Inhaled corticosteroids daily dose
The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 6 months, 12 months, 18 months and 24 months