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 sites134 target enrollmentFebruary 15, 2008

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2008

End Date

February 16, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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.