A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil

NCT04228588 | Unknown Phase 4

• 2 other identifiers: SDC 4863/19/082ISS 212936
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The anti-interleukin-5 monoclonal antibody mepolizumab is approved as an add-on therapy in Europe, Canada, USA, and other countries, to standard of care for the treatment of patients with severe eosinophilic asthma. Mepolizumab has been shown to reduce exacerbation rates and dependency on oral corticosteroid use in clinical trials in patients with severe eosinophilic asthma compared with placebo, both in addition to standard of care. Other trials had also showed that treatment with mepolizumab resulted in significant improvements in quality of life (SGRQ) and asthma control (ACQ-5 score) . Mepolizumab has only recently been approved in Brazil. There is still no data regarding its efficacy and safety in the Brazilian population and it is important to emphasize that no Brazilian center participated in the previous large, international and multicentric phase III mepolizumab studies. Therefore, it is crucial to perform a local study in order to validate external results in the Brazilian population.

Conditions

Eosinophilic Asthma

Keywords

severe asthma; mepolizumab; anti IL-5 monoclonal antibody; pragmatic study

Outcome Measures

Primary Outcomes (1)

• Change in total score of Saint George's Respiratory Questionnaire (SGRQ) between Week 0 and Week 48

  This scales varies from 0 to 100. Higher values means worse quality of life.

  48 weeks

Secondary Outcomes (5)

• Change in the number of clinically significant exacerbations of asthma as defined by: worsening of asthma which requires use of systemic corticosteroids* and/or hospitalisation and/or Emergency Department (ED) visits.

  48 weeks

• Change in lung function (Forced expiratory volume in first second - FEV1)

  48 weeks

• Change of asthma control measured by Asthma control questionnaire (ACQ) 5

  48 weeks

• Safety measured by the number of adverse events

  48 weeks

• Change of asthma control measured by Asthma Control Test (ACT)

  48 weeks

Other Outcomes (4)

• Change of small airway involvement measured by forced oscillometry technique (R5-R20)

  48 weeks

• Change of quality of life measured by Asthma Quality of Life Questionnaire (AQLQ)

  48 weeks

• Change of airway inflammation measured by fraction of exhaled nitric oxide (FeNO)

  48 weeks

Study Arms (1)

Mepolizumab

EXPERIMENTAL

Mepolizumab 100mg, SC, every 4 weeks

Drug: Mepolizumab 100 MG [Nucala]

Interventions

Mepolizumab 100 MG [Nucala] DRUG

Mepolizumab 100mg, SC, every 4 weeks

Mepolizumab

Eligibility Criteria

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

You may qualify if:

• years or older with severe eosinophilic asthma
• Regular use of high-dose inhaled corticosteroids plus other controller medicines
• Non-controlled asthma characterized by ACQ-5 \> 1.5 OR chronic oral corticosteroids asthmatic patients (Prednisone 5mg or more for at least 3 months) even if ACQ-5 \< 1.5
• History of at least one exacerbation requiring treatment with systemic corticosteroids in the previous 12 months before screening OR chronic oral corticosteroids asthmatic patients (Prednisone 5mg or more for at least 3 months) even without exacerbations
• Blood eosinophil count of at least 300 cells per μL within the 12 months before screening OR a blood eosinophil count of at least 150 cells per μL at screening

You may not qualify if:

• Current smokers or former smokers with a history of at least ten pack-years
• Individuals with a concurrent respiratory disease
• Those who had received omalizumab within 30 days before screening
• Patients with severe or clinically significant cardiovascular disease, or other eosinophilic diseases.
• Patients with asthma exacerbation 4 weeks before screening for the study
• Patients with parasitic infection in the 6 months before study entry.
• Patients with substantial uncontrolled comorbidity, possibility of pregnancy
• Patients with history of poor treatment adherence

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Eosinophilia; Asthma

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

Study Officials

• Rodrigo A Athanazio, MD, PhD

  Medical Assistant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo A Athanazio, MD, PhD

CONTACT

+551126615000; rathanazio@yahoo.com.br

Luciana Cassimiro

CONTACT

+551126615109; luciana.cassimiro@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase IV, single-arm study Number of visits: 13 (W-4, W0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48) (W = week)

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 14, 2020
• Study Start: January 9, 2020
• Primary Completion: January 9, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)