Chronic Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: montelukast
Product Code: MK-0476
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: montelukast
CA
Sponsors
Merck & Co Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; Primary end point(s): Change from baseline in FEV1 over treatment period; Change from baseline in FEV1 over at Week 2 | — |
Countries
United Kingdom
Outcome results
None listed