Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Study Overview
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Brief Summary
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Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.

Official Title
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An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage Peak expiratory flow is > or = 80% of predicted value on the day of visit 1 Uncontrolled as per Canadian asthma consensus guidelines Exclusion Criteria: Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>montelukast sodium | Drug: montelukast sodium<br>* montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment<br>* Other names: Singulair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control | Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered yes to at least 2 of the 8 asthma control parameters. | 8 weeks (from Week 0 to Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score | Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score | 8 weeks (from Week 0 to Week 8) | 
| Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale. | 8 weeks (from Week 0 to Week 8) |