Intragastric Balloon in Obese Patients With Uncontrolled Asthma

Официальное название

Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Intragastric balloon device
  Patients in the experimental arm will benefit from the placement of an Intra Gastric Balloon endoscopically
• Процедура Dietary
  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).
• Процедура Exercise intervention
  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.

Первичные конечные точки

• Asthma Control Survey [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Asthma control [Срок оценки: 6 months, 18 months and 24 months]
• Weight loss [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• The number of patients with an Asthma Control Questionnaire score ≤ 1 [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• The change of exacerbations [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• The change of hospital admissions or emergency visits for asthma exacerbation [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• Inhaled corticosteroids daily dose [Срок оценки: 6 months, 12 months, 18 months, 24 months.]
• Forced expiratory volume in 1 second [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• vital capacity [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• Total lung capacity [Срок оценки: 6 months, 12 months, 18 months and 24 months]
• Asthma quality [Срок оценки: 6 months, 12 months, 18 months and 24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• University Hospital Toulouse — Toulouse

Идентификаторы

NCT: NCT05364957 · RC31/18/0473 · 2019-A00595-52

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗