A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients

CompletadoFase 2ClinicalTrials.gov

ID: NCT01197794Tipo: INTERVENTIONALInicio: 1 de oct de 2010Fin estimado: 1 de feb de 2012

Traducción no disponible, mostrando original

Resumen

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
months history of asthma according to ATS definition
Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
A total ACQ5 score of 1.5 or more

Criterios de exclusión

Respiratory infection significantly affecting the asthma
Any significant disease and disorder that may put the patient at risk or influence study results
Any clinically relevant abnormal findings
A smoking history of more than 10 pack years
Intake of oral, rectal or parenteral glucocorticosteroids

Intervenciones

drug

AZD1981

AZD1981 twice daily

drug

AZD1981

AZD1981 once daily

drug

Placebo

Placebo to match AZD1981

Ubicaciones

Research Site

Buenos Aires, Argentina, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalAstraZeneca

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