A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01914757Tipo: INTERVENTIONALInicio: 1 de ago de 2013Fin estimado: 1 de mar de 2016

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Provision of informed consent prior to any study specific procedures
Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (\>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Criterios de exclusión

Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
Affect the safety of the patient throughout the study
Influence the findings of the studies or their interpretations
Impede the patient's ability to complete the entire duration of study
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Intervenciones

biological

Benralizumab

Benralizumab subcutaneously on study week 0 until study week 52 inclusive.

biological

Placebo

Placebo subcutaneously on study week 0 until study week 52 inclusive.

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Caba, Argentina

Research Site

Ciudad Autónoma de Bs. As., Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Concepción del Uruguay, Argentina

Research Site

Corrientes, Argentina

Research Site

Córdoba, Argentina

Research Site

Florida, Argentina

Research Site

Godoy Cruz, Argentina

Research Site

La Plata, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Mendoza, Argentina

Research Site

Ranelagh, Argentina

Research Site

Rosario, Argentina

Research Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAstraZeneca

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