TELICAST : Telithromycin in Acute Exacerbations of Asthma
Status:
Completed
Trial end date:
2004-05-01
Target enrollment:
Participant gender:
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.