Trial | NCT00641680  Report issue

Title

Rhinocort Aqua Versus Placebo and Fluticasone Propionate
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    750
The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Study Started
Apr 30
2003
Primary Completion
Jul 31
2003
Study Completion
Jul 31
2003
Last Update
Jan 24
2011
Estimate

Drug Budesonide

  • Other names: Rhinocort AQUA

Drug Fluticasone propionate

  • Other names: Flonase®

Drug Placebo

1 Experimental

Budesonide

2 Active Comparator

Fluticasone propionate

3 Placebo Comparator

Criteria 

Inclusion Criteria:

At least a 2 year documented history of seasonal allergic rhinitis
who, 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 positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of the study.

Exclusion Criteria:

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 specifies in the protocol.
No Results Posted