Study of GW685698X In Patients With Seasonal Allergic Rhi... | NCT00363740

Studies
Study of GW685698X In Patients With Seasonal Allergic Rhinitis

NCT00363740

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 31, 2018Actual

Enrollment

38Actual

Phase

Phase 3

Conditions

Rhinitis, Allergic, Seasonal

Interventions

GW685698X Aqueous Nasal Spray

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2005

Primary Completion Date

Apr 1, 2005Actual

Completion Date

Apr 13, 2005Actual

First Submitted Date

Aug 11, 2006

First Submission Date that Met QC Criteria

Aug 11, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2018

Last Update Posted Date

Aug 31, 2018Actual

Description Module

Brief Summary

This study was designed to compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray and commonly used drug 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. Typical symptoms are sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Name	Type	Description	Arm Group Labels	Other Names
GW685698X Aqueous Nasal Spray	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline over the entire treatment period in three total nasal symptom scores.

Secondary Outcomes

Measure	Description	Time Frame
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
Mean change from baseline over the entire treatment period in individual total nasal symptom scores.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Informed consent
Outpatient
Diagnosis of seasonal allergic rhinitis with symptoms
Able to comply with study procedures

Exclusion Criteria:

Significant concomitant medical condition
Use of corticosteroids/allergy medications
Laboratory abnormality
Positive pregnancy test
Allergy to any component of investigational product

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided