EUCTR2014-004776-27-Outside-EU/EEA进行中（未招募）不适用
A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK-0476 in Patients with Chronic Asthma - Safety and Bronchodilatory Effects of MK-0476 in Patients with Chronic Asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- •Patient is a female or male outpatient between 15 and 65 years of age.
- •Patient has a FEV1, while withholding short-acting ß2-agonist (SABA) for at least 6 hours, between 50% and 85% of predicted, documented at either Visits 1 or 2.
- •Patient has evidence of reversible airway obstruction, defined by an increase in FEV1 of =12%, compared with the pre-SABA baseline FEV1 (measured in liters), as assessed between 20 and 30 minutes after SABA administration and as documented at Visits 1 and 2.
- •Patient takes an inhaled SABA (e.g., albuterol) as needed for asthma, and has had no change in any asthma controller medication taken (including the dosage of asthma controller medication) within 4 weeks prior to Visit 1.
- •Patient is judged to be in stable health (except for asthma variability) on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, unable to read or comprehend written material, or unable to comply with the study procedures or protocol.
- •Patient is hospitalized or has been hospitalized in the 4 weeks prior to Visit 1.
- •Patient has undergone any major surgical procedure within 4 weeks prior to Visit 1.
- •Patient has been treated in an emergency room for asthma within 4 weeks of Visit 1 or has been hospitalized for asthma within 2 months prior to Visit 1.
- •Patient has had a respiratory tract infection which necessitated treatment with antibiotics within 2 months prior to Visit 1 or a respiratory tract infection which did not require treatment with antibiotics (e.g., viral) within 4 weeks prior to Visit 1.
- •Patient has taken any of the following anti-asthma medications or plans to take such medications during the study: Oral, intravenous, intramuscular, or rectal corticosteroids within 4 weeks prior to Visit 1; Leukotriene synthesis inhibitors within 7 days before Visit 1; Inhaled long- or short-acting anticholinergic agents within 7 days before Visit 1; Leukotriene receptor antagonists within 7 days before Visit 2; Inhaled long-acting ß2-agonist (LABA) or fixed-dose combination of inhaled corticosteroid (ICS) and LABA (e.g., fluticasone/salmeterol, ADVAIR ; or budesonide/formoterol, SYMBICORT ) within 7 days before Visit 2
- •Patient has taken any of the following medications prior to a study visit: Any SABA (such as albuterol) within 6 hours of a scheduled study visit; Any ICS within 1 hour of a scheduled study visit; Any medication containing an antihistamine within 48 hours of a scheduled study visit.
- •Patient has a history of hypersensitivity to aspirin and/or nonsteroidal anti-inflammatory medication.
- •Patient has used any medication with a narrow therapeutic index (e.g., warfarin, dicoumarol, digoxin, digitoxin) within 2 weeks prior to Visit 1 or plans to take such medications during the study.
研究者
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