Status:

COMPLETED

New Nasal Applicator / New Formulation - User Study

Lead Sponsor:

AstraZeneca

Conditions:

Seasonal Allergic Rhinitis

Eligibility:

All Genders

6+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of sea...

Eligibility Criteria

Inclusion

  • In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
  • A documented history of at least one year of seasonal allergic rhinitis.
  • A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study.

Exclusion

  • Primary or secondary adrenal insufficiency
  • Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
  • A diagnosis of asthma requiring treatment as specified in the protocol.

Key Trial Info

Start Date :

April 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2002

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00641979

Start Date

April 1 2002

End Date

August 1 2002

Last Update

January 24 2011

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