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

Severe Eosinophilic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03739320
• Other study ID #: 451
• Status: Recruiting
• Start date: December 11, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Sotiria General Hospital
• Contact: Marios Panagiotou, MD
• Phone: +306974238267
• Email: mpanagiotou[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pulmonary Eosinophilia
• Severe Eosinophilic Asthma

Intervention

Drug:
• Mepolizumab 100 MG Injection [Nucala]
100 milligrams subcutaneously once every 4 weeks

Locations

Country	Name	City	State
Greece	Sotiria General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Sotiria General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

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