Last updated: 11/04/2018 06:59:54
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
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 and active (prednisone) controlled, 6-week study of the effect of fluticasone furoate aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in adolescents and adults 12 to 65 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 compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.
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:
Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).
Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg
Deepen Patel, Paul Ratner, Diane Clements, Wei Wu, Melissa Faris, Edward Philpot. Lack of effect on adult and adolescent HPA axis function with use of fluticasone furoate nasal spray. Ann Allergy Asthma Immunol. 2008;100(5):490-496.
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
January 2005 to May 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 65 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.
- Use of tobacco products.
- Work a rotating shift.
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:
- Use of tobacco products.
- Work a rotating shift.
- Significant concurrent medical conditions.
- Certain medications such as corticosteroids and allergy medications.
Trial location(s)
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
2005-31-05
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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