TELICAST : Telithromycin in Acute Exacerbations of Asthma

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00273520
First received: January 6, 2006
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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.

Condition Intervention Phase
Asthma
Drug: Telithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patient's daily diary summary symptom scores/Morning diary PEFR [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Evening diary PEFR, and diary PEFR variability [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Time to symptom resolution from study entry acute exacerbation of asthma [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Study Start Date: January 2003
Study Completion Date: May 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00273520

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Gilles Perdriset Sanofi
  More Information

Publications:
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00273520     History of Changes
Other Study ID Numbers: HMR3647A_3503
Study First Received: January 6, 2006
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014