Phase 4
Completed N=22
Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis
Source: ClinicalTrials.gov NCT02402465 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge — -33.61; -82.2; -185.85; -41.87 ng/mL — p=>0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Dymista, a combined product containing the antihistamine azelastine and the intranasal steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of efficacy not only occurs at the initiation of treatment, but persists for its duration. The mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on examining the effects of Dymista on the dynamics of the allergic response in man using nasal provocation with antigen. The investigators will study the relationship between symptoms, physiology, cells and mediators.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Response in Albumin Levels in Nasal Lavage Following Each Challenge |
-33.61; -82.2; -185.85; -41.87; -29.70; -81.6 | >0.05 |
| SECONDARY Sneezes After Allergen Challenge |
6.2; 6.8; 1.1; 9.3; 7.6; 2.0 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 55 years of age.
- History of grass and/or ragweed allergic rhinitis.
- Positive skin test to grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
- Off all anti-allergic medications for a minimum of 2 weeks.
Exclusion Criteria
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
Data sourced from ClinicalTrials.gov (NCT02402465). 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.