New Nasal Applicator / New Formulation - User Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641979

Purpose

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 seasonal allergic rhinitis (SAR).

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: budesonide Device: Budesonide Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) [ Time Frame: 2 weekly ]

Secondary Outcome Measures:

Durability of device [ Time Frame: End of study ]
Safety assessment via adverse events and clinical measurements [ Time Frame: 2 weekly ]

Estimated Enrollment:	200
Study Start Date:	April 2002
Study Completion Date:	August 2002
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Rhinocort	Drug: budesonide Current product Device: Budesonide New type device
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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 specified in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641979

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Shaile Shah, MD	Allergy & Asthma Consultant, NJ, USA.
Study Director:	Bertil Andersson	AstraZeneca

More Information

No publications provided

Study ID Numbers:	SD-005-0698, D5360C00698
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00641979 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea

Sneeze
budesonide
Rhinocort AQUA

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Rhinitis
Hormones
Glucocorticoids
Pharmacologic Actions

Nose Diseases
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 25, 2009