Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
Кључне речи
Апстрактан
Опис
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).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, C-reactive Protein (CRP), Interleukin-6 (IL-6), leptin and adiponectin Lung Function/inflammometry - peak expiratory flow (PEF) (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test (practice test and repeat test)[29], Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy. Participants will be given the Actigraph device and asked to wear it continuously for 7 days on their non-dominant wrist, then hand it back.
Participants will be provided with a Personalized Asthma Management Plan, and Symptoms Diary that includes SABA use and other healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions); inhaler technique will be corrected if necessary.
Participants will be randomized 1:1 to Group A and Group B. Group A will enter the Counterweight Plus programme and Group B will enter the usual care arm.
Participants will return for Visit 2 at 16 weeks and Visit 3 at 52 weeks.
Measurements taken at Visits 2 and 3 will include:
Demographics - medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions since last visit), weight, height, and BMI.
Questionnaires - MRC dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, CRP, IL-6, leptin and adiponectin Lung Function/inflammometry - PEF (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test, Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy Visits will be postponed by 4 weeks in the event of exacerbation or respiratory infection. Throughout the study period changes to asthma medications will be allowed as clinically indicated.
Rescue Package for weight regain or re-emergence of diabetes Some patients find weight maintenance difficult, some relapse temporarily and gain weight rapidly. Others may tend to let things slip more gradually. Pilot studies showed the value of a sympathetic, but firm approach to relapse/regain management. If weight regains occurs in TDR randomised participants, or if diabetes is found to have returned (HbA1c risen above 6.5%) at any time during the 18 month weight loss maintenance stage, 'rescue plans' for weight gain prevention will be offered.
1. Weight regain of >2kg: offer the use of TDR to replace one main-meal per day for 4 weeks, and offer orlistat 120 mg tid, with each meal.
2. Weight gain of >4kg, or to <15kg below starting weight or if diabetes recurs: offer 4 weeks TDR with fortnightly weekly practice nurse/dietitian review and then a 2-4 week food re-introduction (adding 1 meal/week as before). Lowfat dietary advice and physical activity will be reinforced for weight maintenance and orlistat treatment will be offered.
This package can be repeated as required in each year of the maintenance phase.
Датуми
| Последња верификација: | 07/31/2019 |
| Фирст Субмиттед: | 02/26/2019 |
| Предвиђена пријава послата: | 02/26/2019 |
| Прво објављено: | 02/28/2019 |
| Послато последње ажурирање: | 08/11/2019 |
| Последње ажурирање објављено: | 08/12/2019 |
| Стварни датум почетка студије: | 08/11/2019 |
| Процењени датум примарног завршетка: | 09/30/2020 |
| Предвиђени датум завршетка студије: | 09/30/2020 |
Стање или болест
Интервенција / лечење
Dietary Supplement: Counterweight Plus
Other: Usual asthma care
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Counterweight Plus Total Diet Replacement phase (0-12 weeks) 825-853kcal/day low energy liquid diet (LELD) for 12 weeks Food Reintroduction phase (13-18 weeks) Wk 13: 400kcal/d LELD + 1 low-fat meal/day (c. 360-400 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1000kcal/day Wk 15: 200kcal/d LELD + 2 low-fat meals/day (c. 720-800 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1200kcal/day.
Wk 17: 3 low-fat meals per day (c.1080-1200 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1400kcal/day.
Weight maintenance phase (wks 19-52) Low-fat healthy eating weight loss maintenance intervention [target below 30% energy from fat, with flexibility to optimise individual compliance, to a maximum of 35%] | Dietary Supplement: Counterweight Plus Total diet replacement followed by food reintroduction and weight maintenance. |
| Active Comparator: Usual asthma care Usual asthma management | Other: Usual asthma care Usual asthma management |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: 1. 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 2. 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 3. BMI ≥ 30 kg/m2 Exclusion Criteria: 1. ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation 2. Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks 3. Significant respiratory or other co-morbidity likely to influence the conduct of the study 4. Pregnancy and breast feeding 5. Severe and/or unstable cardiac disease 6. Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for > 6months or discontinued 7. Current insulin use 8. Current treatment with anti-obesity drugs |
Исход
Примарне мере исхода
1. Asthma Control overall change [Baseline to week 16]
Секундарне мере исхода
1. Asthma control change comparing groups [Baseline to week 16]
2. Asthma Quality of Life overall change [Baseline to week 16]
3. Asthma Quality of Life improvement: % [Baseline to seek 16]
4. Asthma control long term [Baseline to 52 weeks]
5. Asthma quality of life long term: AQLQ score [Baseline to 52 weeks]
6. Treatment burden [Baseline to 16 weeks]
7. Treatment burden long term [Baseline to 52 weeks]
8. Healthcare use [Baseline to 16 weeks]
9. Healthcare use long term [Baseline to 52 weeks]
