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Clinical Trials/NCT03739320
NCT03739320
Unknown
Not Applicable

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

Sotiria General Hospital1 site in 1 country50 target enrollmentDecember 11, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Eosinophilic Asthma
Sponsor
Sotiria General Hospital
Enrollment
50
Locations
1
Primary Endpoint
Change in daily movement intensity
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 11, 2017
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sotiria General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Marios Panagiotou

Respiratory Physician, PhD student

Sotiria General Hospital

Eligibility Criteria

Inclusion Criteria

  • Severe asthma
  • 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

Outcomes

Primary Outcomes

Change in daily movement intensity

Time Frame: 7 days

Movement intensity in m/s\^2

Change in daily moving time

Time Frame: 7 days

Moving time in minutes

Change in daily time in moderate-to-vigorous-intensity activity

Time Frame: 7 days

Time in moderate-to-vigorous-intensity activity in minutes

Change in daily steps

Time Frame: 7 days

Step count

Study Sites (1)

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