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Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis

NCT02230696 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 951

Last updated 2021-10-22

Study results available
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Summary

To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray

137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate

DRUG

Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray

137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate

DRUG

Placebo nasal spray

Placebo nasal spray

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
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 NCT02230696 on ClinicalTrials.gov