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A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma

A Prospective Observational Study on the Effect of Mepolizumab add-on Therapy on Daily Physical Activity in Patients With Severe Eosinophilic Asthma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03739320
Enrollment
50
Registered
2018-11-13
Start date
2017-12-11
Completion date
2019-12-31
Last updated
2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Eosinophilic Asthma

Keywords

severe asthma, biologic therapy, physical activity monitoring

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).

Interventions

100 milligrams subcutaneously once every 4 weeks

Sponsors

Sotiria General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Severe asthma 2. Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.

Exclusion criteria

Comorbidities limiting physical activity

Design outcomes

Primary

MeasureTime frameDescription
Change in daily moving time7 daysMoving time in minutes
Change in daily movement intensity7 daysMovement intensity in m/s\^2
Change in daily time in moderate-to-vigorous-intensity activity7 daysTime in moderate-to-vigorous-intensity activity in minutes
Change in daily steps7 daysStep count

Countries

Greece

Contacts

Primary ContactMarios Panagiotou, MD
mpanagiotou@med.uoa.gr+306974238267
Backup ContactNikoletta Rovina, MD
nikrovina@med.uoa.gr+306945830212‬

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026