Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Asthma Control Survey
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Asthma Control Survey
时间窗: 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.
次要结局
- Total lung capacity(6 months, 12 months, 18 months and 24 months)
- Asthma control(6 months, 18 months and 24 months)
- Weight loss(6 months, 12 months, 18 months and 24 months)
- The change of exacerbations(6 months, 12 months, 18 months and 24 months)
- The change of hospital admissions or emergency visits for asthma exacerbation(6 months, 12 months, 18 months and 24 months)
- Inhaled corticosteroids daily dose(6 months, 12 months, 18 months, 24 months.)
- Forced expiratory volume in 1 second(6 months, 12 months, 18 months and 24 months)
- vital capacity(6 months, 12 months, 18 months and 24 months)
- Asthma quality(6 months, 12 months, 18 months and 24 months)
- The number of patients with an Asthma Control Questionnaire score ≤ 1(6 months, 12 months, 18 months and 24 months)