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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 主要终点
- Patient's daily diary summary symptom scores/Morning diary PEFR
研究概览
简要总结
Primary Objective:
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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:
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Changes in the diary card summary symptom score assessed daily for 6 weeks, and
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Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral telithromycin treatment
Secondary Objectives:
The secondary objectives of the study are:
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To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:
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Assessment of the patient's clinical improvement relative to initial C. pneumoniae or M. pneumoniae status, and
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Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae by culture and quantitative Polymerase Chain Reaction (PCR).
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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
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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:
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Changes and daily variability in the PEFR during the 6 weeks of study treatment,
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Health status at follow-up (6 weeks)
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Pulmonary function tests:
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Forced Expiratory Volume in 1 second (FEV1)
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Forced Vital Capacity (FVC)
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Forced Expiratory Flow Rate (FEF25-75%)
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Need for additional medications (e.g., inhaled corticosteroids, oral corticosteroids, bronchodilator use),
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Time to next acute exacerbation of asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient's daily diary summary symptom scores/Morning diary PEFR
时间窗: During the Study Conduct
次要结局
- 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)