Status:
UNKNOWN
Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
Conditions:
Asthma
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 co...
Detailed Description
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. Eligi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03858608
Start Date
August 12 2019
End Date
August 1 2023
Last Update
April 19 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom