Reslizumab in patients with severe asthma who failed to respond to omalizumab

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 < 20, exacerbations) or adverse effects. Omalizumab must have been used for at least a minimum of 16 weeks.
5- Patients with a high blood eosinophil count (400 µl) at least once in the previous 3 years.
6- 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.
7- 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.
8- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.