Study In Adults And Adolescents With Seasonal Allergic Rhinitis.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00225823

Enrollment

288

Registered

2005-09-26

Start date

2005-05-31

Completion date

2005-08-31

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Seasonal Allergic Rhinitis Intranasal Corticosteroid

Brief 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.

Interventions

DRUGGW685698X

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS).	—

Secondary

Measure	Time frame
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.	—

Countries

Estonia, Latvia, Lithuania, Netherlands, Russia, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026