Rhinocort Aqua Versus Placebo and Fluticasone Propionate
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: Budesonide (Drug); Fluticasone propionate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Michael E Ruff, MD, Principal Investigator, Affiliation: Pharmaceutical Research, Dallas, USA
Summary
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
Secondary outcome: To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. Safety assessment via adverse events and clinical measurements.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2003
Ending date: September 2003
Last updated: March 21, 2008
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