Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545844
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|