A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
CompletadoFase 3ClinicalTrials.gov
ID: NCT00073177Tipo: INTERVENTIONALInicio: 1 de nov de 2003
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
Elegibilidad
Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL
Criterios de inclusión
Persistent bronchial asthma
No change in asthma treatment within 4 weeks prior to visit 1
Non-smoker or ex-smoker (for 12 months or longer)
Criterios de exclusión
Poorly controlled asthma or seasonal asthma
History of lower airway infection four weeks prior to visit 1
Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
Patients using \> 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
Patients with chronic heart failure
Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study
Intervenciones
drug
Roflumilast
Ubicaciones
ALTANA Pharma
Cities in Argentina, Argentina
Patrocinadores
PrincipalAstraZeneca
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