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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Eosinophilic Asthma
• Intervention / Treatment: Drug: Mepolizumab 100 MG Injection [Nucala]

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).

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Marios Panagiotou, MD; Phone Number: +306974238267; Email: mpanagiotou@med.uoa.gr
• Study Contact Backup: Name: Nikoletta Rovina, MD; Phone Number: +306945830212‬; Email: nikrovina@med.uoa.gr

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Sotiria General Hospital
    • Contact: Marios Panagiotou, MD; Phone Number: +00306974238267; Email: mpanagiotou@med.uoa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily moving time	Moving time in minutes	7 days
Change in daily movement intensity	Movement intensity in m/s^2	7 days
Change in daily time in moderate-to-vigorous-intensity activity	Time in moderate-to-vigorous-intensity activity in minutes	7 days
Change in daily steps	Step count	7 days

Collaborators and Investigators

• Sponsor: Sotiria General Hospital
• Investigators: Principal Investigator: Marios Panagiotou, MD, Sotiria General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: biologic therapy; severe asthma; physical activity monitoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: 451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No