Children, Perennial Allergic Rhinitis (PAR), l-t Growth - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00641212

Purpose

The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: Budesonide Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.

Resource links provided by NLM:

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in height over a 12 month period [ Time Frame: 3 monthly ]

Secondary Outcome Measures:

Change in growth velocity over a 12 month period. [ Time Frame: 3 monthly ]
Other safety - assessed by adverse event query [ Time Frame: 3 monthly ]

Estimated Enrollment:	209
Study Start Date:	January 2000
Study Completion Date:	April 2003
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Budesonide	Drug: Budesonide
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	4 Years to 10 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 at least one year of perennial allergic rhinitis.
A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
Height and weight within normal limits.

Exclusion Criteria:

Any disease which may affect growth
Sexual development later than Tanner stage I.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641212

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Bertil Andersson

AstraZeneca

More Information

No publications provided

Study ID Numbers:	SD-005-0414, D5360C00414
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00641212 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Allergic rhinitis
Perennial allergic rhinitis
Paediatric

Growth
budesonide
Rhinocort AQUA

Study placed in the following topic categories:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Rhinitis
Hormones
Glucocorticoids

Hypersensitivity
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on July 02, 2009