Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00273520
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TELICAST : Telithromycin in Acute Exacerbations of Asthma
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: