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 II

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 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
Experimental: 1 Rhinocort	Drug: budesonide Current product Other Name: Rhinocort AQUA Device: Budesonide New type device Other Name: Rhinocort Aqua
Placebo Comparator: 2	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

ClinicalTrials.gov Identifier:	NCT00641979 History of Changes
Other Study ID Numbers:	SD-005-0698, D5360C00698
Study First Received:	March 18, 2008
Last Updated:	January 21, 2011
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:

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

ClinicalTrials.gov processed this record on February 09, 2012