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TELICAST : Telithromycin in Acute Exacerbations of Asthma

NCT00273520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2009-09-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Telithromycin

Sponsors & Collaborators

Principal Investigators

  • Gilles Perdriset · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2004-04-30
Completion
2004-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00273520 on ClinicalTrials.gov