TELICAST : Telithromycin in Acute Exacerbations of Asthma
Summary
Primary 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.
Timeline
- Start
- 2003-01
- Primary completion
- 2004-04
- Completion
- 2004-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telithromycin | Small molecule | 800 mg | Oral |