The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound GW685698X compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in children 2 to 11 years of age with perennial allergic rhinitis.

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: GW685698X aqueous nasal spray	Phase III

Further Study Details: 

Primary Outcomes: HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects.
Secondary Outcomes: Adverse events; Laboratory values; Nasal examination; Vital signs; ECG assessments; Pharmacokinetic assessments
Expected Total Enrollment:  90

Ages Eligible for Study:  2 Years   -   11 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis and history of perennial allergic rhinitis.
• Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
• Must comply with all study procedures and be literate.

Exclusion Criteria:

• Significant concurrent medical conditions
• Certain medications such as corticosteroids and allergy medications are excluded during the study.

Arkansas
      Brian Jackson, Hot Springs,  Arkansas,  71913,  United States
      Jerry Herron, Little Rock,  Arkansas,  72202,  United States
California
      Javier Quesada, Long Beach,  California,  90806,  United States
Florida
      Kathryn Blake, Jacksonville,  Florida,  32207,  United States
      Isaac Marcadis, West Palm Beach,  Florida,  33409,  United States
Louisiana
      Bradley Chastant, Lafayette,  Louisiana,  70506,  United States
Missouri
      Ita Tripathy, Rolla,  Missouri,  65401,  United States
Oregon
      Paul Matz, Medford,  Oregon,  97504,  United States
South Carolina
      Richard Sterling, Orangeburg,  South Carolina,  29118,  United States
      Arden Levy, Spartanburg,  South Carolina,  29307,  United States
Texas
      Paul Ratner, San Antonio,  Texas,  78229,  United States
Virginia
      Anne-Marie Irani, Richmond,  Virginia,  23219,  United States

Study chairs or principal investigators

GSK Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  FFR100012
Last Updated:  August 1, 2005
Record first received:  June 30, 2005
ClinicalTrials.gov Identifier:  NCT00116883
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02