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A Study Comparing the Bioequivalence of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray (Apotex, Inc.) to That of Dymistaâ„¢ Nasal Spray (Meda Pharmaceuticals, Inc.) in the Treatment of Seasonal Allergic Rhinitis

NCT02279563 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 595

Last updated 2014-10-31

No results posted yet for this study

Summary

This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymistaâ„¢ Nasal Spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymistaâ„¢ nasal spray.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray

During the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days. During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days

DRUG

Dymistaâ„¢ Nasal Spray

DRUG

Placebo

Sponsors & Collaborators

  • Apotex Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-02-28

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Entities

Drugs

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 NCT02279563 on ClinicalTrials.gov