Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05364957

Intragastric Balloon in Obese Patients With Uncontrolled Asthma

Led by University Hospital, Toulouse · Updated on 2025-12-31

84

Participants Needed

1

Research Sites

324 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intragastric Balloon in Obese Patients With Uncontrolled Asthma

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged between 18 and 65 years
  • Asthma diagnosed according to the Global Initiative for Asthma (GINA) criteria
  • Uncontrolled asthma with an ACQ score 1.5 despite inhaled corticosteroids � long acting bronchodilators (LABA)
  • Grade I obesity (BMI > 30 kg/m8 and < 35 kg/m8) or morbid obesity (BMI <40 or 35 kg/m8 with serious physiological risks) with contraindications for or refusal of bariatric surgery
  • Effective contraception for women
  • Signed written informed consent form
  • Health insurance coverage
  • Complete COVID-19 vaccination schedule according to current guidelines
Not Eligible

You will not qualify if you...

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Blood eosinophilia greater than 4.5 G/I
  • Treatment by biotherapy within 12 months after inclusion
  • Cancer diagnosed within the last 5 years
  • Smoking more than 10 packs/year
  • Asthma exacerbation in the 4 weeks prior to inclusion or IGB placement
  • Treatment with orlistat (X�nical�) or GLP1 analogues or regular use of narcotics (heroin, cocaine, amphetamines); analgesics including level 3 allowed
  • Contraindications to IGB including severe cognitive or psychiatric disorders, chronic alcoholism, drug addiction
  • Severe and unstable eating disorders such as bulimia or history of anorexia
  • History of gastric surgery including ring insertion
  • Haemostasis disorders
  • Use of anticoagulant or non-steroidal anti-inflammatory medicines
  • Severe liver disease
  • Pregnancy, breastfeeding, or desire to become pregnant
  • Anticipated failure to comply with prolonged medical follow-up
  • Large hiatal hernias > 5 cm, inflammatory bowel disease (Crohn's), pyloric stenosis, or digestive tract structural abnormalities
  • Systemic lupus erythematous
  • Severe oesophagitis and active gastroduodenal ulcer
  • Silicone allergy
  • Persons under guardianship, tutorship, or protection of justice
  • Participation in another study with an ongoing exclusion period

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Toulouse

Toulouse, Occitanie, France, 31000

Actively Recruiting

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Research Team

G

Guilleminault Laurent, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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