A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma
- Conditions
- Severe Eosinophilic Asthma
- Registration Number
- NCT03739320
- Lead Sponsor
- Sotiria General Hospital
- Brief Summary
Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.
- Detailed Description
A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Severe asthma
- Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.
Comorbidities limiting physical activity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in daily movement intensity 7 days Movement intensity in m/s\^2
Change in daily moving time 7 days Moving time in minutes
Change in daily time in moderate-to-vigorous-intensity activity 7 days Time in moderate-to-vigorous-intensity activity in minutes
Change in daily steps 7 days Step count
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sotiria General Hospital
🇬🇷Athens, Greece