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Keep this study
Lead
Sanofi
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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:
* 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
Clareo Health | TELICAST : Telithromycin in Acute Exacerbations of Asthma
