Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00273520
Brief 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.
Study:
NCT00273520
Study Brief:
Protocol Section:
NCT00273520