Phase 4
N=313
Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00545844 ↗Enrolled (actual)
313
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: Primary: Asthma Control — 312; 72; 0; 229 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- montelukast sodium (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2008
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 |
Summary
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
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.