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
- Conditions
- Chronic AsthmaMedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
- Registration Number
- EUCTR2007-006097-28-GB
- Lead Sponsor
- Merck & Co Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 134
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1) To demonstrate that treatment with montelukast and mometasone, compared with mometasone alone, results in improvement in FEV1 in patients aged 15 to 85 years with chronic asthma; 2) To determine the safety and tolerability of montelukast and mometasone, compared with mometasone alone, in patients aged 15 to 85 years with chronic asthma.;Secondary Objective: 1) To demonstrate that montelukast and mometasone, compared with mometasone alone, results in improvement in asthma symptoms scores (both daytime and nighttime) in patients aged 15 to 85 years with chronic asthma.;<br> Primary end point(s): Change from baseline in FEV1 over treatment period;<br> Change from baseline in FEV1 over at Week 2<br>
- Secondary Outcome Measures
Name Time Method