Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared with Inhaled Corticosteroid Therapy Alone in Patients with Chronic Asthma

Merck & Co Inc.,0 个研究点目标入组 134 人开始时间: 2008年2月15日最近更新: 2019年11月25日

适应症

试验速览

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•The patient has received treatment with short-acting inhaled ß-agonist, and may have received treatment with Inhaled Corticosteroid (ICS) at any dose or combination therapy of ICS and long-acting beta-agonist (LABA) at any dose during the 4 weeks prior to Visit 1.
•Patient has a FEV1, while withholding ß-agonist for at least 6 hours, between 50% and 80% of predicted, documented on at least two of the following visits: Visits 1, 2, and 3.
•Patient has evidence of reversible airway obstruction, as defined by an increase in FEV1 of =12% of predicted between 20 to 30 minutes after inhaled ß-agonist administration documented according to ONE of the following criteria:
•1) reversibility at Visit 3 AND on at least one of two visits (Visits 1, and 2); OR,
•2) reversibility at Visit 3 AND also documented at one visit at the study center within 1 year prior to study participation.
•Patient meets the minimum requirements for the overall Daytime Symptoms Score and ß-agonist use.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient is hypersensitive to inhaled ß-agonists, corticosteroids, leukotriene antagonists, or any of their components.
•Patient has taken any of the following anti-asthma medications or plans to take such medications during the study:
•- Inhaled long or short-acting anticholinergic agents within 2 weeks of Visit 1;
•- Oral, intravenous, intramuscular, or rectal corticosteroids within 4 weeks prior to Visit 1;
•- Xanthine derivatives or xanthine combinations within 2 weeks prior to Visit 1;
•- Leukotriene-receptor antagonists within 3 days prior to Visit 1;
•- Leukotriene synthesis inhibitors within 2 weeks prior to Visit 1;
•- Omalizumab (Xolair®) within 4 weeks prior to Visit 1.
•Patient is unable to perform acceptable, reproducible spirometry.
•Patient has required an oral corticosteroid rescue for worsening asthma during the screening period.

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