Long Term Safety Of GW685698X Via Nasal Biopsy

Rhinitis, Allergic, Perennial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224523
• Other study ID #: FFR104503
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: October 27, 2016
• Start date: September 2005
• Est. completion date: February 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• GW685698X

• mometasone furoate

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Leuven
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment.
Secondary	No Secondary Outcome Measures

External Links

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