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

NCT03739320 | Unknown DMC FDA Drug

• 1 other identifier: 451
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Eosinophilic Asthma

Keywords

severe asthma; biologic therapy; physical activity monitoring

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Mepolizumab 100 MG Injection [Nucala] DRUG

100 milligrams subcutaneously once every 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Severe asthma
• Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.

Sponsors & Collaborators

• Sotiria General Hospital: lead

Study Sites (1)

Sotiria General Hospital

Athens, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

Interventions

mepolizumab; Injections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Marios Panagiotou, MD

  Sotiria General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marios Panagiotou, MD

CONTACT

+306974238267; mpanagiotou@med.uoa.gr

Nikoletta Rovina, MD

CONTACT

+306945830212‬; nikrovina@med.uoa.gr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory Physician, PhD student

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 13, 2018
• Study Start: December 11, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

GR (1)