Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma

NCT05063981 | Completed FDA Drug

• 1 other identifier: Pascale 09/2020
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Understanding how Interleukin-5 blockade modulates both immune and metabolic pathways may clarify the multidimensional impact of biologic therapy in severe eosinophilic asthma. Therefore, this study aimed to assess the impact of mepolizumab on the nasal, bronchial, and systemic metabolomic profiles of consecutive patients with SEA and to explore the associations between these compartment-specific changes and clinical, inflammatory, and functional outcomes.

Conditions

Severe Eosinophilic Asthma

Keywords

asthma; chronic respiratory disease; mepolizumab; rehabilitation; inflammation

Outcome Measures

Primary Outcomes (2)

• Number of exacerbations

  episodes of acute worsening of symptoms

  Baseline T0; 6 months (T6); 12 months (T12)

• Asthma Control Test (ACT)

  patient self-reported questionnaire, score

  Baseline T0; 6 months (T6); 12 months (T12)

Secondary Outcomes (5)

• Inflammatory markers (Interleukins, TGF-beta, GM-CSF)

  Baseline T0; 6 months (T6); 12 months (T12)

• 1H-NMR-based metabolomic profiling

  Baseline T0; 6 months (T6); 12 months (T12)

• peripheral blood eosinophil count (BEC)

  Baseline T0; 6 months (T6); 12 months (T12)

• Forced expiratory volume (FEV1)

  Baseline T0; 6 months (T6); 12 months (T12)

• Fractional Exhaled nitric oxide (FeNO)

  Baseline T0; 6 months (T6); 12 months (T12)

Study Arms (1)

Severe eosinophilic asthma

Patients with severe refractory eosinophilic asthma

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

The effects of treatment with Mepolizumab were evaluated on clinical and laboratory markers of systemic inflammation during a 12 months follow-up period in multiple biological matrices.

Severe eosinophilic asthma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will enroll patients with severe refractory eosinophilic asthma for whom treatment with mepolizumab is indicated, according to the AIFA recommendations.

You may qualify if:

• Eligibility for mepolizumab treatment according to clinical practice;
• age between 18 and 75 years;
• diagnosis of severe eosinophilic refractory asthma, defined as peripheral blood eosinophil count (BEC) \> 300 cells/μL and at least two documented exacerbations within the previous 12 months;
• ongoing treatment with high daily doses of inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABA), plus at least one additional controller medication for a minimum of 12 months.

You may not qualify if:

• current smoking;
• diagnosis of other chronic pulmonary diseases;
• coexisting chronic rhinosinusitis with nasal polyps;
• use of systemic corticosteroids at any dose within the 6 weeks prior to enrollment;
• use of immunosuppressive therapies;
• receipt of live attenuated vaccines within 30 days prior to enrollment;
• current or recent history (within the last 5 years) of malignancy, except in cases of complete remission;
• diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA);
• upper or lower respiratory tract infections within 30 days prior to signing informed consent or during the screening/run-in period;
• any clinically significant abnormalities identified during screening through physical examination, vital signs assessment, hematology, or clinical chemistry, which, in the opinion of the investigator, could pose a risk to patient safety or interfere with study outcomes or compliance.
• known immunodeficiency (primary or secondary);
• pregnancy;
• concurrent treatment with other biologics for asthma or other conditions (except for stable allergen immunotherapy, defined as an unchanged dose and regimen at screening); prior biologic therapy for asthma within 6 months before starting mepolizumab; planned surgical procedures during the study period;
• participation in another interventional or post-authorization safety study.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Palermo: collaborator
• National Research Council: collaborator

Study Sites (2)

Istituti Clinici Scientifici Maugeri IRCCS

Telese Terme, BN, 82037, Italy

Location

Istituti Clinici Scientifici Maugeri IRCCS

Tradate, Varese, Italy

Location

Related Publications (1)

• Maniscalco M, Ambrosino P, Candia C, Di Stefano A, Gnemmi I, Zappa M, Ambrosino N, Visca D, Motta A. Cytokine and Metabolomic Signatures of Mepolizumab Response Across Upper and Lower Airway Compartments in Severe Eosinophilic Asthma: An Exploratory Analysis. Pharmaceuticals (Basel). 2025 Nov 10;18(11):1704. doi: 10.3390/ph18111704.

  PMID: 41304949 RESULT

Related Links

• Pubblication

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, serum, nasal secretions, exhaled breath condensate

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma; Inflammation

Interventions

mepolizumab

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: October 1, 2021
• Study Start: November 25, 2021
• Primary Completion: September 29, 2023
• Study Completion: September 2, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

IT (2)