Calendario›SNY›Telithromycin
Telithromycin
TELICAST : Telithromycin in Acute Exacerbations of Asthma
Ensayo de Sanofi en Asma.
Más ensayos de: Asma.
- Fase
- Fase 3
- Estado
- Completado
- Fin del objetivo primario
- abr 2004
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en ene 2003.
Qué mide
Patient's daily diary summary symptom scores/Morning diary PEFR (During the Study Conduct) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: * The primary objective is to evaluate the clinical efficacy of telithromycin versus placebo as a supplement to the usual standard of care during an acute exacerbation of asthma. Efficacy will be assessed by: * Changes in the diary card summary symptom score assessed daily for 6 weeks, and * Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral telithromycin treatment Secondary Objectives: The secondary objectives of the study are: * To evaluate the microbial activity of telithromycin during an exacerbation of asthma by: * Assessment of the patient's clinical improvement relative to initial C. pneumoniae or M. pneumoniae status, and * Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae by culture and quantitative Polymerase Chain Reaction (PCR). * To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard of care for patients with acute exacerbations of asthma * To assess additional efficacy endpoints and health outcome evaluations following 10 days of treatment with either oral telithromycin or placebo, with either treatment used as a supplement to the standard of care for patients with acute exacerbations of asthma: * Changes and daily variability in the PEFR during the 6 weeks of study treatment, * Health status at follow-up (6 weeks) * Pulmonary function tests: * Forced Expiratory Volume in 1 second (FEV1) * Forced Vital Capacity (FVC) * Forced Expiratory Flow Rate (FEF25-75%) * Need for additional medications (e.g., inhaled corticosteroids, oral corticosteroids, bronchodilator use), * Time to next acute exacerbation of asthma.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00273520), actualizada en sep 2009.