A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

CompletadoFase 2ClinicalTrials.gov

ID: NCT01130064Tipo: INTERVENTIONALInicio: 1 de may de 2010Fin estimado: 1 de abr de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Male and female patients
Female patients must be surgically sterilized or postmenopausal
Male patients must use two forms of contraception
Body mass index must be between 18 and 39 kg/m2
Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists

Criterios de exclusión

Smoking history \>10 pack-years
Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening
History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

Intervenciones

biological

QAX576

every 3 weeks via intravenous infusion

drug

Placebo

every 3 weeks via intravenous infusion

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Mendoza, Argentina

Novartis Investigative Site

Santa Fe, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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