Last updated: 11/04/2018 06:57:02
Long Term Safety Of GW685698X Via Nasal Biopsy
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects 18 Years of Age with Perennial Allergic Rhinitis (PAR)
Trial description: Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Timeframe: N/A
Secondary outcomes:
No Secondary Outcome Measures
Timeframe: N/A
Interventions:
Enrollment:
125
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Fokkens W, Hellings P, Blom H, Jansen A, van Drunen K, Clements D, Wu W, Caldwell M, Philpot E. A comparison of the effects of fluticasone furoate and mometasone furoate nasal sprays on the nasal mucosa. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A12 (abstract)
Wyske Fokkens, Bas Rinia, Cornelis van Drunen, Peter Hellings, Greet Hens, Ad Jansen; Henk Blom, Wei Wu, Diane Clements, Laurie Lee, Ed Philpot .No mucosal atrophy and reduced inflammatory cells: active-controlled trial with yearlong fluticasone furoate nasal spray.Am J Rhinol Allergy.2012;26(1):36-44
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
September 2005 to February 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Inclusion criteria:
- History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen.
- Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control. Exclusion criteria:
- Patients who require certain medications for their allergy.
- Patients with serious medical problems.
Trial location(s)
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-01-02
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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