Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225823
• Other study ID #: FFR103184
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: September 13, 2016
• Start date: May 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Informed consent.

• Must be an outpatient.

• Females must be using appropriate contraception.

• Must have diagnosis of seasonal allergic rhinitis, adequate exposure to allergen.

• Must be able to comply with study procedures.

• Must be literate.

Exclusion criteria:

• A significant concomitant medical condition.

• Use of corticosteroids or allergy or medications or tobacco.

• Clinically significant abnormal ECG.

• Laboratory abnormality.

• Positive pregnancy test.

• Allergy to any component of the investigational product.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• GW685698X

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Latvia	GSK Investigational Site	Liepaja
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Siauliai
Lithuania	GSK Investigational Site	Vilnius
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Arnhem
Netherlands	GSK Investigational Site	Assen
Netherlands	GSK Investigational Site	Leeuwarden
Netherlands	GSK Investigational Site	Schiedam
Netherlands	GSK Investigational Site	Tilburg
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Volgograd
Sweden	GSK Investigational Site	Ängelholm
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Estonia,  Latvia,  Lithuania,  Netherlands,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).
Secondary	Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy.

External Links

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