TELICAST : Telithromycin in Acute Exacerbations of Asthma

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00273520
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2004-04
• Study Completion: 2004-05
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient's daily diary summary symptom scores/Morning diary PEFR	During the Study Conduct

Secondary Outcome Measures

Name	Time	Method
In-clinic pulmonary function tests: Forced expiratory volume in 1 second (FEV1), Percent predicted FEV1, Forced vital capacity (FVC), Forced expiratory flow rate at 25% to 75% of FVC (FEF25-75), PEFR, and percent predicted PEFR	During the study conduct
Evening diary PEFR, and diary PEFR variability	During the study conduct
Time to symptom resolution from study entry acute exacerbation of asthma	During the study conduct