Phase 3
Completed N=348
Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)
Source: ClinicalTrials.gov NCT01915823 ↗Enrolled (actual)
348
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Primary Efficacy — -3.83; -2.77 units on a scale
Summary
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to <12 years old who have seasonal allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy |
-3.83; -2.77 | — |
| SECONDARY Safety |
28; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects ages >4 years to 50% of entries
- Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimens following a brief period of missed injections do not preclude participation). Dose reduction when a new bottle is used does not preclude participation.
- Planned travel outside of the pollen area during the study period
Data sourced from ClinicalTrials.gov (NCT01915823). 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.