Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sociedad Española de Neumología y Cirugía Torácica
With
Teva Pharmaceuticals USA
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients between 18 and 70 years of age,
Patients diagnosed with severe uncontrolled asthma
Patients who give informed consent.
Previous treatment with omalizumab that was discontinued because lack of efficacy (symptoms -ACT \<20, exacerbations) or adverse effects.
Patients with a high blood eosinophil count (400 μl) at least once in the previous 3 years.
Women should be surgically sterilized, at least 2 years have passed since menopause, or must have a negative pregnancy test within 7 days prior to initiation of treatment.
Women of childbearing potential (not surgically sterilized or menopausal for less than 2 years) should use a medically accepted method of contraception and should agree to continue using this method during the study and at least 30 days after the end of the study.
Patient should be willing and able to comply with the study restrictions and attend the visits indicated in the protocol to carry out the follow-up evaluations detailed in the protocol.
You may not be if
Diagnosis of asthma-COPD (Chronic Obstructive Pulmonary Disease) overlap syndrome.
Active and former smokers of\>10 packages / year.
Exacerbations during the previous 4 weeks.
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.
Participation in another clinical trial.
Uncontrolled clinically significant disease, which may interfere with study procedures, interpretation of efficacy results, or compromise patient safety.
Underlying lung disorder.
Known hypereosinophilic syndrome.
A pregnant or lactating woman, or who intends to become pregnant during the study.
Participation in a clinical trial within 30 days prior to the start of treatment.
Previous exposure to reslizumab or other anti-IL-5 monoclonal antibody.
Immunodeficiency disorder, including HIV.
Suspected drug or alcohol abuse.
Active helminth parasite infection or for which treatment was received in the 6 months prior to the start of treatment.
History of allergic reaction or hypersensitivity to any component of the study drug.
