Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
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|ClinicalTrials.gov Identifier: NCT00545844|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : August 19, 2009
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: montelukast sodium||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||313 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 1, 2007|
|Actual Primary Completion Date :||January 1, 2008|
|Actual Study Completion Date :||January 1, 2008|
Drug: montelukast sodium
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Other Name: Singulair
- Asthma Control [ Time Frame: 8 weeks (from Week 0 to Week 8) ]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.
- The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score [ Time Frame: 8 weeks (from Week 0 to Week 8) ]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
- 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) [ Time Frame: 8 weeks (from Week 0 to Week 8) ]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.
- Patient Global Satisfaction [ Time Frame: 8 weeks (from Week 0 to Week 8) ]At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
- Physician Global Satisfaction [ Time Frame: 8 weeks (from Week 0 to Week 8) ]At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.
- Patient Global Allergic Rhinitis Symptoms Assessment [ Time Frame: 8 weeks (from Week 0 to Week 8) ]At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545844
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|