A Pragmatic, Randomised, Controlled, Trial of the Effect of the Counterweight Plus Weight Management Programme in Uncontrolled Asthma Associated With Elevated Body Mass Index
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Asthma Control overall change
研究概览
简要总结
Weight loss for uncontrolled asthma associated with elevated BMI. Asthma is a common condition with different types recognised that have variable responses to current treatments. It is often poorly controlled and there is a need to discover new treatments. Obesity is common in asthma and is associated with increase in symptoms, poorer asthma control and quality of life, and increased healthcare utilisation and treatment burden. The Counterweight Plus programme is a safe, evidence-based non-surgical intervention that is associated with sustained weight losses of up to 15% in obese individuals but its effects in asthma have not been tested. Our study aims to evaluate the impact of this intervention in individuals with difficult asthma associated with obesity.
The Counterweight Plus programme includes a total diet replacement (TDR) phase (12 weeks) followed by structured food reintroduction (6 weeks) and long term weight loss maintenance (34 weeks) and will be provided by Dieticians trained in the delivery of this intervention. Participants will attend fortnightly clinic reviews with Dieticians during the first 18 weeks and then monthly clinic reviews during the weight loss maintenance period.
Participants will be randomised to Counterweight Plus programme or usual care (control) and followed for 1 year with study visits at baseline, 4 months and 1 year. During study visits participants will be invited to complete questionnaires, provide a blood sample, perform breathing tests and a walking test, and wear an activity monitor for one week.
If the Counterweight Plus programme is proven to be of benefit in this patient group, this may lead to service development so that this intervention may be made available to similar patients in the future within the clinical setting.
详细描述
This study will be a unblinded, pragmatic, pilot, randomised, controlled trial of the Counterweight Plus programme versus usual care in individuals with difficult asthma associated with obesity. Eligible individuals will be identified through Difficult Asthma Clinics or ward admissions. Those wishing to participate will receive an information sheet and be invited to provide written informed consent prior to commencing the study.
Baseline Visit
Measurements taken at the baseline visit will include:
Demographics - age, gender, smoking history (current, ex, none, years since stopped, pack years), age at asthma diagnosis, duration of asthma, atopy, co-morbidities (allergic/perennial rhinitis, nasal polyps, nasal surgery, eczema, gastro-oesophageal reflux disease, diabetes, hypertension, cardiac disease, osteopenia/osteoporosis etc), medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled General Practitioner (GP) or Accident + Emergency (A+E) attendances, hospital and Intensive Care Unit (ICU) admissions in preceding year), weight, height and BMI.
Questionnaires - Medical Research Council (MRC) dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:
- •Reversible airflow limitation - 12% and 200ml increase in forced expiratory volume (FEV1) in the preceding 5 years either: i. After inhaled/nebulised bronchodilator or 4+ weeks of anti-inflammatory treatment ii. Between visits
- •Positive bronchial challenge in the preceding 5 years: i. Provocation concentration (PC20) methacholine or histamine <8mg/ml ii. Provocative dose (PD15) mannitol <635mg
- •Difficult asthma defined as per Scottish Intercollegiate Guidelines Network (SIGN)/British Thoracic Society (BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:
- •ACQ6 >1.5
- •≥2 systemic corticosteroid boosts in previous year
- •≥1 hospitalization in previous year
- •BMI ≥ 30 kg/m2
排除标准
- •ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation
- •Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
- •Significant respiratory or other co-morbidity likely to influence the conduct of the study
- •Pregnancy and breast feeding
- •Severe and/or unstable cardiac disease
- •Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for > 6months or discontinued
- •Current insulin use
- •Current treatment with anti-obesity drugs
结局指标
主要结局
Asthma Control overall change
时间窗: Baseline to week 16
Change in score of ACQ6 (Asthma Control Questionnaire 6) in intervention group versus usual care group. Score range 0 - 36 with higher scores representing a worse outcome
次要结局
- Asthma quality of life long term: AQLQ score(Baseline to 52 weeks)
- Treatment burden(Baseline to 16 weeks)
- Asthma control change comparing groups(Baseline to week 16)
- Asthma Quality of Life overall change(Baseline to week 16)
- Asthma Quality of Life improvement: %(Baseline to seek 16)
- Treatment burden long term(Baseline to 52 weeks)
- Asthma control long term(Baseline to 52 weeks)
- Healthcare use(Baseline to 16 weeks)
- Healthcare use long term(Baseline to 52 weeks)