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Safety and Efficacy Trial of Dymista Nasal Spray in Children Ages 4 to 11 With Seasonal Allergic Rhinitis (SAR)

NCT01915823 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2015-06-29

Study results available
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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.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

azelastine hydrochloride and fluticasone propionate

DRUG

Dymista vehicle

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01915823 on ClinicalTrials.gov