EUCTR2006-003216-22-IT进行中（未招募）不适用
Effects of montelukast on airway inflammation in allergic children - ND
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2007年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is male or female, at least 6 years of age and no more than 14 years at visit 1. 2. Patient has mild intermittent asthma at step 1 or mild persistent asthma at step 2 of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institute of Health as defined by a history of symptoms twice a week or less step 1 or more than twice a week but less than daily step 2 . 3. Atopic nonasthmatic children with seasonal allergic rhinitis at visit 1 according to ARIA guidelines Allergic Rhinitis and its Impact on Asthma . 4. Current asthma treatment includes short-acting inhaled 61538;-agonist alone as needed. 5. Positive skin prick testing. 6. Patient fulfills all the following signs and symptoms of asthma by visit 2 a History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months. b A forced expiratory volume in one second FEV1 of at least 80 of the predicted value pre-bronchodilator while withholding 61538;-agonist for at least six hours. This must be demonstrated twice at visits 1 and 2. c Patient has a diagnosis of asthma as defined by 1 an increase in FEV1 or PEF of 8805;12 absolute value , 20 to 30 minutes after inhaled 61538;-agonist administration at visits 1, OR 2 a positive methacholine PC20 provocative concentration causing a 20 fall in FEV1 of 8 mg/ml or lower which was performed within the previous 12 months, OR 3 a fall in FEV1 of at least 15 after an exercise challenge which was performed within the previous 12 months. 61538;-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation. 7. Patient is able to chew a tablet. 8. Patient is judged to be in good, stable physical and mental health except for his/her asthma based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial. 9. Ability to perform reproducible spirometry. 10. Nonsmoker including no use of smokeless tobacco products in the past year. 11. Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the institutional review board of the subject s respective study institution, with assent from the child.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Parent/legal guardian is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material. 2. Patient is hospitalized. 3. Patient has undergone any major surgical procedure within four weeks of visit 1. 4. Patient has, in addition to asthma, any active, acute or chronic pulmonary disorder documented by history or physical examination. 5. Patient has ever been intubated for asthma, has required acute asthma therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for asthma within three months of visit 1 or required 2 or more hospitalizations for asthma in the past year. 6. Patient has FEV1 80 predicted on visit 1, nighttime awakenings from asthma 2 or more times per week, or PEF variability of 30 or more. 7. Patient received 4 or more oral corticosteroid bursts for asthma exacerbations. 8. Patient has unresolved symptoms and signs of an upper respiratory tract infection URI within three weeks of visit 1 or during the run-in period. 9. Patient has a history of an anaphylactic allergic reaction related to administration of either a marketed or investigational drug or is otherwise hypersensitive to inhaled 61538;-agonist or oral montelukast or their components. 10. Patient has a clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematological systems, or an immunodeficiency, or an autoimmune disorder. 11. Patient has a history of any illness that would require treatment with an excluded medication, could be immediately life threatening, would pose restriction on participation or successful completion of the study, or would pose an additional risk to the patient by administering the study drug. 12. Patient has taken the following medications 1 Oral, intravenous, intramuscular, intra-articular or inhaled corticosteroids within 4 weeks of visit 1 with the exception of nasal corticosteroids administered on a continuous basis. 2 Leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 2 weeks before visit 1. 3 Received treatment within the previous 4 week with medications known to significantly interact with montelukast. 4 Antibiotics for 61502;7 consecutive days in the 4 weeks prior to visit 1. 5 IV gammaglobulin or immunosuppressants within one month of visit 1. 6 Aspirin and nonsteroidal anti-inflammatory medication within two weeks prior to visit 1. 13. Patient has started immunotherapy within six months of visit 1. 14. Patient is unable or unwilling to comply with the study procedures as determined during the run-in period, including compliance with study medication. 15. Girls for whom onset of pregnancy during the study cannot be excluded.
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