Eosinophilic AsthmaPhase 4NCT04228588
A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil
A Phase 4 study testing Mepolizumab 100 MG [Nucala] in people with Eosinophilic Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eosinophilic Asthma
- What is being tested?
- Mepolizumab 100 MG [Nucala]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Jan 2020to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo, 05403-900
Rodrigo Athanazio, +55 11 2661-5000 ext. 5685, rathanazio@yahoo.com.br
About this study
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.
Read the detailed description
Severe asthma is associated with substantial morbidity, mortality, health-care costs, and impaired quality of life. Recurrent asthma exacerbations are a major problem in some patients and can predominate in a subgroup with eosinophilic airway inflammation. Mepolizumab is a humanised monoclonal antibody against interleukin 5 that effectively inhibits eosinophilic airway inflammation.
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.
Our group belongs to a public academic institution with a focus on assistance, teaching and research. It is a tertiary-referral hospital with an outpatient clinic specializing severe asthma patients. In 2012, the investigators published the first study with the clinical characterization of their cohort of severe asthma and its respective phenotypes. Since then, the investigators have carried out several studies in order to identify prognostic factors and interventions that could improve the control and quality of life of this population. Among them, there are the impact of weight control in asthma symptoms, evaluation of standardized and systematic protocol based on high doses of inhaled corticosteroid plus LABA and 2 weeks course of oral corticosteroids and pathophysiological studies based on bronchial biopsy samples from patients with severe asthma. Since obesity is a serious and prevalent problem in several severe asthma cohorts, another area of interest of the group is to assess the impact of physical activity on this population. Finally, it is important to mention the commitment of the group to evaluate the incorporation of new treatments in the severe asthma population within the Brazilian scenario as done in a specific publication to systematically evaluate the use of omalizumab in our center.
Therefore, the investigators consider that our center has full capacity to conduct a systematic evaluation study of the use of mepolizumab in the population of severe asthma. The investigators aimed to examine the effects of mepolizumab on quality of life, lung function, asthma symptoms and exacerbation rate in patients with severe eosinophilic asthma in a tertiary reference center in Brazil based on real world data.
- Conditions
- Eosinophilic Asthma
- Being tested
- Mepolizumab 100 MG [Nucala]
- Keywords
- severe asthma, mepolizumab, anti IL-5 monoclonal antibody, pragmatic study
- Medical subject headings
- Pulmonary Eosinophilia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab 100 MG [Nucala]Drug
Mepolizumab 100mg, SC, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab | Experimental | Mepolizumab 100mg, SC, every 4 weeks Receives: Drug: Mepolizumab 100 MG [Nucala] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
significant exacerbations are definied as those requiring at least 3 days of systemic corticosteroids
Measured: 48 weeks
Change in lung function (Forced expiratory volume in first second - FEV1)
Measured by spirometry
Measured: 48 weeks
Change of asthma control measured by Asthma control questionnaire (ACQ) 5
ACQ varies from 0 to 5 with higher values meaning worse asthma control.
Measured: 48 weeks
Safety measured by the number of adverse events
number of all adverse events
Measured: 48 weeks
Change of asthma control measured by Asthma Control Test (ACT)
ACT varies from 5 to 25 with higher values meaning better asthma control.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start9 Jan 2020
- Primary completion9 Jan 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo A Athanazio, MD, PhD, Principal investigator, Medical Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228588
- Sponsor's protocol ID
- SDC 4863/19/082
- Other IDs
- ISS 212936
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil
- ClinicalTrials.gov ID
- NCT04228588
- Acronym / sponsor ID
- SDC 4863/19/082
- Conditions
- Eosinophilic Asthma
- Keywords
- severe asthma, mepolizumab, anti IL-5 monoclonal antibody, pragmatic study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe asthma is associated with substantial morbidity, mortality, health-care costs, and impaired quality of life. Recurrent asthma exacerbations are a major problem in some patients and can predominate in a subgroup with eosinophilic airway inflammation. Mepolizumab is a humanised monoclonal antibody against interleukin 5 that effectively inhibits eosinophilic airway inflammation.
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.
Our group belongs to a public academic institution with a focus on assistance, teaching and research. It is a tertiary-referral hospital with an outpatient clinic specializing severe asthma patients. In 2012, the investigators published the first study with the clinical characterization of their cohort of severe asthma and its respective phenotypes. Since then, the investigators have carried out several studies in order to identify prognostic factors and interventions that could improve the control and quality of life of this population. Among them, there are the impact of weight control in asthma symptoms, evaluation of standardized and systematic protocol based on high doses of inhaled corticosteroid plus LABA and 2 weeks course of oral corticosteroids and pathophysiological studies based on bronchial biopsy samples from patients with severe asthma. Since obesity is a serious and prevalent problem in several severe asthma cohorts, another area of interest of the group is to assess the impact of physical activity on this population. Finally, it is important to mention the commitment of the group to evaluate the incorporation of new treatments in the severe asthma population within the Brazilian scenario as done in a specific publication to systematically evaluate the use of omalizumab in our center.
Therefore, the investigators consider that our center has full capacity to conduct a systematic evaluation study of the use of mepolizumab in the population of severe asthma. The investigators aimed to examine the effects of mepolizumab on quality of life, lung function, asthma symptoms and exacerbation rate in patients with severe eosinophilic asthma in a tertiary reference center in Brazil based on real world data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab | Experimental | Drug: Mepolizumab 100 MG [Nucala]Mepolizumab 100mg, SC, every 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab 100 MG [Nucala]Mepolizumab 100mg, SC, every 4 weeks | Drug | Mepolizumab |
Primary outcome
Change in total score of Saint George's Respiratory Questionnaire (SGRQ) between Week 0 and Week 48
Time frame: 48 weeks
This scales varies from 0 to 100. Higher values means worse quality of life.
5 secondary outcomes
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.
Time frame: 48 weeks
Change in lung function (Forced expiratory volume in first second - FEV1)
Time frame: 48 weeks
Change of asthma control measured by Asthma control questionnaire (ACQ) 5
Time frame: 48 weeks
Safety measured by the number of adverse events
Time frame: 48 weeks
Change of asthma control measured by Asthma Control Test (ACT)
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo A Athanazio, MD, PhD principal investigator
Medical Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepolizumab 100 MG [Nucala] in people with Eosinophilic Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo A Athanazio, MD, PhD (+551126615000 ext. 5685, rathanazio@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total score of Saint George's Respiratory Questionnaire (SGRQ) between Week 0 and Week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.