Study Of Perennial Allergic Rhinitis | NCT00358475

Studies
Study Of Perennial Allergic Rhinitis

NCT00358475

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Aug 31, 2018Actual

Enrollment

65Actual

Phase

Phase 3

Conditions

Rhinitis, Allergic, Seasonal

Interventions

GW685698

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

Jun 21, 2005

Primary Completion Date

Oct 1, 2005Actual

Completion Date

Oct 12, 2005Actual

First Submitted Date

Jul 27, 2006

First Submission Date that Met QC Criteria

Jul 27, 2006

First Posted Date

Jul 31, 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 assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis. Perennial allergic rhinitis is triggered by house dust, mite and mold etc. Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.

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

65Actual

Name	Type	Description	Arm Group Labels	Other Names
GW685698	Drug

Measure	Description	Time Frame
Adverse events and laboratory blood test

Measure	Description	Time Frame
Change of nasal symptom score

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Informed consent.
Outpatient.
Diagnosis of perennial 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.

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
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided