A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Telithromycin 800 mg (Once Daily for 10 Days) as a Supplement to the Standard of Care for Patients With Acute Exacerbations of Asthma

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.