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Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

NCT01024608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-12-03

Study results available
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Summary

The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

Conditions

  • Seasonal Allergic Rhinitis
  • Hay Fever

Interventions

DRUG

Beclomethasone dipropionate

Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks.

DRUG

Placebo Nasal Aerosol

Placebo nasal aerosol administered each morning for two weeks.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Sudeesh Tantry, Ph.D. · Teva Branded

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

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 NCT01024608 on ClinicalTrials.gov