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Clinical Equivalence of Azelastine Hydrochloride and Fluticasone Propionate, 137/50 mcg Nasal Spray to Dymista™

NCT02249663 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1535

Last updated 2014-09-25

No results posted yet for this study

Summary

To evaluate the therapeutic equivalence of a test formulation of Azelastine hydrochloride and Fluticasone propionate Nasal Spray to the reference listed drug, Dymista™ Nasal Spray in the relief of the signs and symptoms of Seasonal Allergic Rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Azelastine hydrochloride and Fluticasone propionate

137/50 mcg Nasal Spray

DRUG

Dymista™

137/50 mcg Nasal Spray

OTHER

Placebo

Nasal spray with no pharmaceutically active content

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Darin Brimhall, DO, FACP · Novum Pharmaceutical Research Services

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28

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 NCT02249663 on ClinicalTrials.gov