Last updated: 11/04/2018 07:02:06
Perennial Allergic Rhinitis Study In Pediatric Subjects
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A two week randomized, double blind placebo controlled, parallel group study of GW685698X Aqueous Nasal Spray 100mcg and 50mcg QD in pediatric subjects with Perennial Allergic rhinitis
Trial description: The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW685698X
Enrollment:
558
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract).
Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol.
Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008;138(1): 30 - 37.
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.
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
February 2005 to November 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2 - 12 years
Accepts healthy volunteers
No
- Diagnosis of perennial allergic rhinitis.
- Have significant concomitant medical conditions.
- Use of corticosteroids or other allergy medications during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of perennial allergic rhinitis.
Exclusion criteria:
- Have significant concomitant medical conditions.
- Use of corticosteroids or other allergy medications during the study.
- Have abnormal ECG.
- Have laboratory abnormality.
- Have abnormal eye exam.
Trial location(s)
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 8724
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80112
Status
Study Complete
Location
GSK Investigational Site
Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Liverpool, New York, United States, 13090
Status
Study Complete
Location
GSK Investigational Site
Costa Mesa, California, United States, 92626
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37922
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Ithaca, New York, United States, 14850
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Cudahy, California, United States, 90201
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Monticelli Ascoli Piceno, Italy, 63100
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203-1424
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
Status
Study Complete
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Pennsylvania, United States, 15202
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14627
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
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
2005-23-11
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.
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