Weight Loss for Uncontrolled Asthma Associated With Elevated BMI (NCT03858608) | Clinical Trial Compass
UnknownNot Applicable
Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
United Kingdom40 participantsStarted 2019-08-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:
. 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:
. BMI ≥ 30 kg/m2
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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