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Intragastric Balloon in Obese Patients With Uncontrolled Asthma (BOA)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intragastric balloon device
Dietary
Exercise intervention
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Intra Gastric Balloon, uncontrolled asthma, Obesity with asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 depite 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 Haute Autorité de Santé- 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 athorized during the study.

  8. Any patient for whom IGB is contraindicated [criteria defined by the Société Française d'Endoscopie Digestive (SFED - French Society for Digestive Endoscopy) and the Club de Réflexion du Groupe des Cabinets d'Hépato-Gastroentérologie (CREGG) - French Think-Tank for Hepato-Gastroenterology Practices]:

    8.1 Severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction 8.2 Severe and ustalibilished eating disorders: bulimia or history of anorexia 8.3 Historiy of gastic surgery including the ring insertion 8.4 Haemostasis disorders 8.5 Anticoagulant or non-steroidal anti- inflammatory mdicines 8.6 Severe liver disease 8.7 Pregnancy or disire 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 tuesteeship, persons placed under the protection of justice or persons participating in another search including an exclusion period still in progress

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control (PEC dietary hygiene)

Experimental (BIG + PEC dietary hygiene)

Arm Description

Diet and exercise alone (control)

Intragastric balloon combined with diet and exercise (active)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)).
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
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
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.
Inhaled corticosteroids daily dose
The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline
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.
vital capacity
The change of vital capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.
Total lung capacity
the change of total lung capacity value measured by plethysmography, and fractions of exhaled nitric oxide (FENO) compared to baseline.
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

Full Information

First Posted
April 21, 2022
Last Updated
June 14, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05364957
Brief Title
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
Acronym
BOA
Official Title
Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Intra Gastric Balloon, uncontrolled asthma, Obesity with asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control (PEC dietary hygiene)
Arm Type
Other
Arm Description
Diet and exercise alone (control)
Arm Title
Experimental (BIG + PEC dietary hygiene)
Arm Type
Experimental
Arm Description
Intragastric balloon combined with diet and exercise (active)
Intervention Type
Device
Intervention Name(s)
Intragastric balloon device
Intervention Description
Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
Intervention Type
Procedure
Intervention Name(s)
Dietary
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Exercise intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control Survey
Description
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
Secondary Outcome Measure Information:
Title
Asthma control
Description
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
Title
Weight loss
Description
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
Title
The number of patients with an Asthma Control Questionnaire score ≤ 1
Description
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
Title
The change of exacerbations
Description
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
Title
The change of hospital admissions or emergency visits for asthma exacerbation
Description
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
Title
Inhaled corticosteroids daily dose
Description
The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline
Time Frame
6 months, 12 months, 18 months, 24 months.
Title
Forced expiratory volume in 1 second
Description
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
Title
vital capacity
Description
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
Title
Total lung capacity
Description
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
Title
Asthma quality
Description
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
Other Pre-specified Outcome Measures:
Title
Physical activity
Description
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
Time Frame
6 months, 12 months, 18 months and 24 months
Title
Immunoglobulin E (IgE) repertoire of B-lymphocytes
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Blood eosinophilia greater than 4.5 G/I Treatment by biotherapy within the 12 months after inclusion Cancer diagnosed within the last 5 years Smoking > 10 packs/year (PA) One asthma exacerbation in the 4 weeks leading up to the inclusion visit or IGB placement. 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]: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guilleminault Laurent, MD
Phone
05 67 77 18 50
Ext
33
Email
guilleminault.l@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilleminault M Laurent, MD
Organizational Affiliation
Study principal Investigator Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
State/Province
Occitanie
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Intragastric Balloon in Obese Patients With Uncontrolled Asthma

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