Last updated: 11/07/2018 16:42:02
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, double-blind, parallel group, placebo controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in children 2 to 11 years of age with perennial allergic rhinitis (PAR).
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
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
Timeframe: N/A
Secondary outcomes:
Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.
Timeframe: N/A
Interventions:
Drug: GW685698X aqueous nasal spray
Enrollment:
90
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Meltzer EO, Tripathy I, Máspero JF, Wu W and Philpot EE. Safety and Tolerability of Fluticasone Furoate Nasal Spray Once Daily in Pediatric Patients Aged 6 to 11 Years with Allergic Rhinitis. Clin Drug Invest. 2009;29(2):79-86.
Tripathy I, Levy A, Ratner P, Clements D, Wu W and Philpot E. HPA axis safety of fluticasone furoate nasal spray once daily in children with perennial allergic rhinitis. Pediatric Allergy and Immunology. 2009;20(3):287–294.
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
February 2005 to July 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2 - 11 years
Accepts healthy volunteers
No
- 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.
- Significant concurrent medical conditions.
- Certain medications such as corticosteroids and allergy medications.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72202
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-07-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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