Assess the Efficacy and Safety of Rhinocort Aqua - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641693

Purpose

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Budesonide Drug: Placebo	Phase II

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, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.

Resource links provided by NLM:

MedlinePlus related topics: Caregivers

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers. [ Time Frame: At 2 weeks ]

Secondary Outcome Measures:

Safety assessment via adverse events and clinical measurements [ Time Frame: At 1 & 2 weeks ]
To assess efficacy of Rhinocort via the physician and caregivers assessments [ Time Frame: At 2 weeks ]

Estimated Enrollment:	650
Study Start Date:	April 2004
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nasal Spray	Drug: Budesonide 16mg Nasal Spray Drug: Budesonide 32mg Nasal Spray Drug: Budesonide 64mg Nasal Spray
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	2 Years to 5 Years
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 allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
At randomisation having nasal symptom scores as defined by the protocol.

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: NCT00641693

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Liza O'Dowd, MD	AstraZeneca
Study Director:	Bertil Andersson	AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5360C00703, SD-005-0703
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00641693 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Allergic rhinitis
Paediatric
Nasal symptoms
Congestion

Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA

Additional relevant MeSH terms:

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

Glucocorticoids
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 25, 2009