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Status unknownNCT03739320Updated Nov 13, 2018

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

An observational study in Severe Eosinophilic Asthma, sponsored by Sotiria General Hospital. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-13.

Sponsored by Sotiria General Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Severe Eosinophilic Asthma

Keywords

  • severe asthma
  • biologic therapy
  • physical activity monitoring
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

This is the only study on the registry with Sotiria General Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with severe asthma, already on maximal and optimised treatment who fulfil the criteria for mepolizumab add-on therapy.

Eligibility criteria

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

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Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DrugMepolizumab 100 MG Injection [Nucala]

    100 milligrams subcutaneously once every 4 weeks

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What researchers measure

Primary outcomes

  1. Change in daily moving time

    Moving time in minutes

    Time frame: 7 days

  2. Change in daily movement intensity

    Movement intensity in m/s\^2

    Time frame: 7 days

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

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

    Time frame: 7 days

  4. Change in daily steps

    Step count

    Time frame: 7 days

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Study locations

1 of 1 sites recruiting
  • Sotiria General Hospital
    Athens, 11527, Greece
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03739320
Lead sponsor
Sotiria General Hospital
Responsible party
Marios Panagiotou (Respiratory Physician, PhD student, Sotiria General Hospital) — Principal investigator
First posted
Nov 13, 2018
Start date
Dec 11, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Nov 13, 2018

Study contacts

Marios Panagiotou, MD
Contact
mpanagiotou@med.uoa.gr
+306974238267
Nikoletta Rovina, MD
Contact
nikrovina@med.uoa.gr
+306945830212‬
Marios Panagiotou, MD
principal investigator · Sotiria General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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