Severe asthma MedDRA version: 19.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: CINQAERO
Product Name: Reslizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RESLIZUMAB
CAS Number: 241473-69-8
Other descriptive name: RESLIZUMAB
Conc
Sponsors
Respira. Fundación Española del Pulmón (SEPAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Patients between 18 and 70 years of age, 2- Patients diagnosed with severe uncontrolled asthma 3- Patients who give informed consent. 4- Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms –ACT =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1- Diagnosis of asthma-COPD overlap syndrome. 2- Active and former smokers of> 10 packages / year. 3- Exacerbations during the previous 4 weeks. 4- Current treatment with omalizumab or last dose of omalizumab in the 5 months prior to inclusion of the patient in the study. 5- Exposure to another monoclonal antibody. 6- Participation in another clinical trial. 7- Uncontrolled clinically significant disease, which may interfere with study procedures, interpretation of efficacy results, or compromise patient safety. 8- Underlying lung disorder. 9- Known hypereosinophilic syndrome. 10- A pregnant or lactating woman, or who intends to become pregnant during the study. 11- Participation in a clinical trial within 30 days prior to the start of treatment. 12- Previous exposure to reslizumab or other anti-IL-5 monoclonal antibody. 13- Immunodeficiency disorder, including HIV. 14- Suspected drug or alcohol abuse. 15- Active helminth parasite infection or for which treatment was received in the 6 months prior to the start of treatment. 16- History of allergic reaction or hypersensitivity to any component of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of reslizumab (3mg/kg) administered every four weeks on asthma symptoms at week 24.;Secondary Objective: - Effect of reslizumab on asthma symptoms (ACQ-7 items) at week 24. - Effect of reslizumab on asthma symptoms (Asthma Control Test: ACT and ACQ-7 items) at weeks 4 and 12. - Effect of reslizumab on particular items of the ACT and ACQ-7 items (diurnal dyspnea, nocturnal awakenings, early morning symptoms, activity limitations, wheezing, use of rescue medication) at weeks 4, 12 and 24. - Effect of reslizumab on the rate of patients who achieve the minimally important difference of the ACT and ACQ at week 24. - Effect of reslizumab on peripheral eosinophil count at week 24. - Effect of reslizumab on pulmonary function (FEV1) at weeks 4, 12 and 24. - Effect of reslizumab on severe asthma exacerbations at week 24. - Effect of reslizumab on quality of life (assessed by AQLQ questionnaire) at weeks 4, 12 and 24. - Effect of reslizumab on exhaled nitric oxide levels at week 24. - Evaluation of adverse effects.;Primary end point(s): Difference in Asthma Control Test score (ACT) between baseline and week 24.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1- Week 12 y 24 2- Week 4, 12 y 24 3- Week 4, 12 y 24 4- Week 24 5- Week 24 6- Week 4, 12 y 24 7- Week 24 8- Week 4, 12 y 24 9- Week 24 10- Every month;Secondary end point(s): 1- Difference in the score of Asthma Control Test (ACT) between baseline and weeks 4 and 12. 2- Score difference of the 7-item Asthma Control Questionnaire (ACQ) between baseline and weeks 4, 12 and 24. 3 - Difference in the ACT and ACQ-7 items related to daytime dyspnoea, nocturnal awakenings, early morning symptoms, activity limitations, wheezing and use of rescue medication at weeks 4, 12 and 24. 4- Percentage of patients that achieve the minimally important difference in ACT and ACQ-7 at week 24 compared to the baseline. 5- Difference in eosinophil count in peripheral blood at week 24 compared to baseline. 6 - Difference in lung function (FEV1) at weeks 4, 12 and 24 compared to baseline. 7- Number of severe exacerbations of asthma during the 24 weeks of the study. 8- Difference in the AQLQ questionnaire score at weeks 4, 12 and 24 compared to baseline. 9- Difference in exhaled nitric oxide levels between baseline and week 24. 10- Number and percentage of patients who have each adverse event. | — |
Countries
Spain
Contacts
Public ContactClinical Operations Department
APICES
Outcome results
None listed