Reslizumab in patients with severe asthma who failed to respond to omalizumab: a pilot study

Respira. Fundación Española del Pulmón (SEPAR)0 个研究点开始时间: 2017年2月16日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Respira. Fundación Española del Pulmón (SEPAR)