ObesityBOANCT05364957
Intragastric Balloon in Obese Patients With Uncontrolled Asthma
A study testing Intragastric balloon device, Dietary and Exercise intervention in people with Obesity and Asthma, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Intragastric balloon device, Dietary and Exercise intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2023to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, Occitanie, 31000
About this study
Official title: Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
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.
Read the 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.
- Being tested
- Intragastric balloon device, Dietary, Exercise intervention
- Keywords
- Intra Gastric Balloon, uncontrolled asthma, Obesity with asthma
- Medical subject headings
- Obesity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric balloon deviceDevice
Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
DietaryProcedure or surgery
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).
Exercise interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| control (PEC dietary hygiene) | Other | Diet and exercise alone (control) Receives: Procedure: Dietary; Procedure: Exercise intervention |
| Experimental (BIG + PEC dietary hygiene) | Experimental | Intragastric balloon combined with diet and exercise (active) Receives: Device: Intragastric balloon device; Procedure: Dietary; Procedure: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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)).
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 months, 12 months, 18 months and 24 months
Inhaled corticosteroids daily dose
The change of inhaled corticosteroids daily dose (in ug/d) compared to baseline
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start12 May 2023
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guilleminault M Laurent, MD, Principal investigator, Study principal Investigator Toulouse University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364957
- Sponsor's protocol ID
- RC31/18/0473
- Other IDs
- 2019-A00595-52
- Acronym
- BOA
- Status last verified
- Dec 2025
- First submitted
- 21 Apr 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05364957
- Acronym / sponsor ID
- BOA / RC31/18/0473
- Keywords
- Intra Gastric Balloon, uncontrolled asthma, Obesity with asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control (PEC dietary hygiene) | Other | Procedure: Dietary, Procedure: Exercise interventionDiet and exercise alone (control) |
| Experimental (BIG + PEC dietary hygiene) | Experimental | Device: Intragastric balloon device, Procedure: Dietary, Procedure: Exercise interventionIntragastric balloon combined with diet and exercise (active) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intragastric balloon devicePatients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically | Device | Experimental (BIG + PEC dietary hygiene) |
| DietaryThe 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 or surgery | Experimental (BIG + PEC dietary hygiene), control (PEC dietary hygiene) |
| Exercise interventionPatient 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. | Procedure or surgery | Experimental (BIG + PEC dietary hygiene), control (PEC dietary hygiene) |
Primary outcome
Asthma Control Survey
Time frame: 12 months
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.
10 secondary outcomes
Asthma control
Time frame: 6 months, 18 months and 24 months
Weight loss
Time frame: 6 months, 12 months, 18 months and 24 months
The number of patients with an Asthma Control Questionnaire score ≤ 1
Time frame: 6 months, 12 months, 18 months and 24 months
The change of exacerbations
Time frame: 6 months, 12 months, 18 months and 24 months
The change of hospital admissions or emergency visits for asthma exacerbation
Time frame: 6 months, 12 months, 18 months and 24 months
Inhaled corticosteroids daily dose
Time frame: 6 months, 12 months, 18 months, 24 months.
Forced expiratory volume in 1 second
Time frame: 6 months, 12 months, 18 months and 24 months
vital capacity
Time frame: 6 months, 12 months, 18 months and 24 months
Total lung capacity
Time frame: 6 months, 12 months, 18 months and 24 months
Asthma quality
Time frame: 6 months, 12 months, 18 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guilleminault M Laurent, MD principal investigator
Study principal Investigator Toulouse University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intragastric balloon device, Dietary and Exercise intervention in people with Obesity and Asthma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guilleminault Laurent, MD (05 67 77 18 50 ext. 33, guilleminault.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Survey (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.