Rhinocort Aqua Versus Placebo and Fluticasone Propionate - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641680

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Budesonide Drug: Fluticasone propionate Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Budesonide Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	750
Study Start Date:	April 2003
Study Completion Date:	July 2003
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Budesonide	Drug: Budesonide Other Name: Rhinocort AQUA
Active Comparator: 2 Fluticasone propionate	Drug: Fluticasone propionate Other Name: Flonase®
Placebo Comparator: 3	Drug: Placebo

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641680

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Michael E Ruff, MD

Pharmaceutical Research, Dallas, USA

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00641680 History of Changes
Other Study ID Numbers:	D5360C00005
Study First Received:	March 18, 2008
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Seasonal allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea
Sneeze

budesonide
Rhinocort AQUA
Fluticasone propionate
Flonase

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Budesonide
Fluticasone
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 12, 2012