Phase 4
Completed N=313
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Source: ClinicalTrials.gov NCT00545844 ↗Enrolled (actual)
313
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcomePrimary: Asthma Control — 312; 72; 0; 229 Participants
Summary
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control |
312; 72; 0; 229; 1; 0 | — |
| SECONDARY The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score |
-1.45 | <0.001 sig |
| SECONDARY 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) |
2.03; 0.92 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00545844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.