Status:
COMPLETED
TELICAST : Telithromycin in Acute Exacerbations of Asthma
Lead Sponsor:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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. E...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00273520
Start Date
January 1 2003
End Date
May 1 2004
Last Update
September 15 2009
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