TELICAST : Telithromycin in Acute Exacerbations of Asthma

NCT00273520 | Completed Phase 3

• 1 other identifier: HMR3647A_3503
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Patient's daily diary summary symptom scores/Morning diary PEFR

  During the Study Conduct

Secondary Outcomes (3)

• 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

Interventions

Telithromycin DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients meeting all of the following criteria will be considered for enrollment in the study:
• A documented history of asthma for \>6 months
• Presenting within 24 hours of initial medical care in an urgent care clinic, emergency room, or in-patient hospital setting. To qualify for enrollment they must present with the following signs and symptoms of an acute deterioration in asthma control: (reduced PEFR, increased wheeze, and dyspnea, with or without cough).
• A PEFR less than 80% of predicted normal
• Females who meet the following conditions:
• postmenopausal for at least 1 year, or
• surgically incapable of bearing children, or
• of childbearing potential, and all of the following conditions are met:
• had a normal menstrual flow within 1 month before study entry and
• has a negative pregnancy test (serum b-subunit human chorionic gonadotropin \[hCG\]) immediately before study entry and
• must agree to abstinence or use of an accepted method of contraception

You may not qualify if:

• Patients presenting with any of the following will not be included in the study:
• Requiring immediate placement in an Intensive Care Unit
• Obvious known allergic precipitant for this episode of acute severe asthma (e.g., acute exposure to animal dander)
• Pneumonia
• Known long QT syndrome or familial history of long QT syndrome (if no previous electrocardiogram \[ECG\] has invalidated this risk factor), or personal history of coronary disease, ventricular arrhythmia, bradycardia \<50 beats/min, or known uncorrected hypokalemia or magnesemia
• Known impaired hepatic or renal function
• Known diagnosis of myasthenia gravis
• Active or quiescent tuberculosis infections of the respiratory tract
• Acute exacerbation of chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, or emphysema
• A history of smoking of 10 pack-years or more
• Women who are breast feeding or are pregnant, as demonstrated by serum or urine pregnancy tests
• Suspected or known hypersensitivity to, or suspected serious adverse reaction to the macrolide class of antibiotics
• A concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that would make implementation of the protocol or interpretation of the study results difficult
• A recent (within the previous 3 months) history of alcohol or recreational drug misuse.
• Immunocompromised patients, including but not limited to:

Sponsors & Collaborators

• Sanofi: lead

Related Publications (1)

• Johnston SL, Blasi F, Black PN, Martin RJ, Farrell DJ, Nieman RB; TELICAST Investigators. The effect of telithromycin in acute exacerbations of asthma. N Engl J Med. 2006 Apr 13;354(15):1589-600. doi: 10.1056/NEJMoa044080.

  PMID: 16611950 RESULT

MeSH Terms

Conditions

Asthma

Interventions

telithromycin

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gilles Perdriset

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2006
• First Posted: January 9, 2006
• Study Start: January 1, 2003
• Primary Completion: April 1, 2004
• Study Completion: May 1, 2004
• Last Updated: September 15, 2009

Record last verified: 2009-09