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

NCT ID: NCT03739320

Last Updated: 2018-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-11

Study Completion Date

2019-12-31

Brief Summary

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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

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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).

Conditions

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Severe Eosinophilic Asthma

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

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Mepolizumab 100 MG Injection [Nucala]

100 milligrams subcutaneously once every 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sotiria General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marios Panagiotou

Respiratory Physician, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marios Panagiotou, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria General Hospital

Locations

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Sotiria General Hospital

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Marios Panagiotou, MD

Role: CONTACT

+306974238267

Nikoletta Rovina, MD

Role: CONTACT

+306945830212‬

Facility Contacts

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Marios Panagiotou, MD

Role: primary

+00306974238267

Other Identifiers

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451

Identifier Type: -

Identifier Source: org_study_id

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