Rhinocort Aqua Versus Placebo and Fluticasone Propionate - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

July 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]
Safety assessment via adverse events and clinical measurements. [ Time Frame: 2 & 4 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Drug: Budesonide
Drug: Fluticasone propionate
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Budesonide
Active Comparator: Fluticasone propionate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

750

Completion Date

July 2003

Primary Completion Date

July 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00641680

Responsible Party

Study ID Numbers ^ICMJE

D5360C00005

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michael E Ruff, MD

Pharmaceutical Research, Dallas, USA

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP