TELICAST : Telithromycin in Acute Exacerbations of Asthma

NCT ID: NCT00273520

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2004-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Telithromycin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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:

• patients with known human immunodeficiency virus (HIV) infection and have either had or have an AIDS defining condition (e.g., Kaposi's sarcoma, Pneumocystis carinii pneumonia) or a CD4 + T lymphocyte count of <200/mL
• patients with neutropenia (<1500 neutrophils/mm3)
• patients with metastatic or hematological malignancy
• splenectomized patients or patients with known hyposplenia or asplenia
• Planned surgical treatment at any time during the course of the study that would be incompatible with the objectives of this study
• Other disease conditions or infections that could interfere with the evaluation of study treatment efficacy or safety
• Oral steroid-dependent asthma
• Antibiotic use within 30 days prior to enrollment
• Treated within 2 weeks prior to inclusion with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, and St. John's Wart
• Currently receiving medication known to prolong QT interval such as cisapride, pimozide, astemizole and terfenadine, or potent CYP3A4 inhibitors such as antiproteases or ketoconazole.
• Patients in whom an antibiotic is clearly indicated.
• Have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow-up phase

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Gilles Perdriset

Role: STUDY_DIRECTOR

Sanofi

References

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.

Reference Type: RESULT

PMID: 16611950 (View on PubMed)

Other Identifiers

HMR3647A_3503

Identifier Type: -

Identifier Source: org_study_id