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A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

NCT00883168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1791

Last updated 2013-06-24

Study results available
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Summary

The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

Placebo

Placebo

DRUG

azelastineHcl

azelastine hydrochloride 548 mg

DRUG

fluticasone propionate

fluticasone propionate 200 mcg

DRUG

azelastine Hcl/fluticasone propionate

azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lewis M Fredane, MD · Meda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00883168 on ClinicalTrials.gov