Phase 4
N=150
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00845195 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline — 4.28; 4.15 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olopatadine HCl Nasal Spray, 0.6% (Drug); Azelastine HCl Nasal Spray, 0.1% (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline |
4.28; 4.15 | — |
| PRIMARY Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline |
4.22; 4.04 | — |
| PRIMARY Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline |
2.64; 2.49 | — |
| PRIMARY Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline |
2.76; 2.54 | — |
Summary
The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Able to provide consent/assent
- History of spring/summer allergic rhinitis
- Positive skin prick and/or intradermal test
- Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
- Non-pregnant (where applicable)
- Able to complete daily diary
Exclusion Criteria
- Smoker
- Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
- History of current chronic sinusitis
- Asthma
- Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
- History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
- History or evidence of nasolacrimal drainage system malfunction
Data sourced from ClinicalTrials.gov (NCT00845195). 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.