Control of Moderate or Severe Asthma With 160, 320 and 640 mcg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01455194Tipo: INTERVENTIONALInicio: 1 de nov de 2011Fin estimado: 1 de ago de 2014

Traducción no disponible, mostrando original

Resumen

The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Written informed consent was provided
History of persistent bronchial asthma for at least 6 months
Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
Good inhalation technique
Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2

Criterios de exclusión

Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months

Intervenciones

drug

Ciclesonide

During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)

Ubicaciones

Buenos Aires, Argentina

Capital Federal, Buenos Aires, Argentina

Rosario, Argentina

Rosario-Santa Fe, Argentina

Salta, Argentina

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalAstraZeneca

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