CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Mepolizumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05147155
NCT05147155N/ACompleted

How Much Severe is the Severe Asthma of Patients Who Will be Medicated With Mepolizumab? Μeasurement of Respiratory Mechanics by Means of Impulse Oscillometry in Severe Eosinophilic Asthmatics Before and After Mepolizumab Initiation

University of Thessaly·observational·Posted Dec 7, 2021·Updated Feb 24, 2025

In Brief

An observational study evaluating Mepolizumab for Severe Asthma. Completed, enrolled 130 participants across 1 site.

Detailed Summary

Eosinophilic inflammation in the small airways of patients with severe asthma is considered to be an important marker of disease severity. In clinical trials, treatment with mepolizumab reduces exacerbation rates by almost a half along with modest improvements in symptom scores and forced expiratory volume in 1 s (FEV1) early after the first month of commencing mepolizumab treatment. However, there is an apparent discrepancy between major patient-reported outcomes and lung function that should be explored. It has recently been reported that mepolizumab improves small airway function in severe eosinophilic asthma as detected by multiple-breath nitrogen washout test. The improvement in small airway function was seen rapidly after the first mepolizumab injection and was associated with a sustained response in the majority of patients. However, gaps in knowledge about the choice of device, gas, and standardization across systems are key issues leading the committee to conclude that multiple-breath nitrogen washout test is not ready for use as a clinical trial endpoint in asthmatics. The investigators hypothesize that early improvement in small airway function may be a significant contributor to the therapeutic response of anti-IL-5 monoclonal antibody therapy in patients with severe uncontrolled eosinophilic asthma. The investigators speculate that SAD could be effectively evaluated using IOS. Consequently, this study could lead to novel SAD subtypes with possible clinical relevance in the context of treatment with anti-IL-5 factor. The investigators hypothesize that healthy individuals and patients with severe controlled asthma would disclose a lesser extent of SAD than patients with severe uncontrolled eosinophilic asthma with or without fixed airway obstruction.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Asthma
CountriesGreece
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 7, 2021
Enrollment StartApr 19, 2021
Primary CompletionOct 23, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.6 years ago

Interventions

Mepolizumabbiological

This will be a 2-year prospective study. Patients with uncontrolled severe asthma will receive mepolizumab according to standard of care and best clinical practice, which will be administered as a 100-mg subcutaneous dose every four weeks.