NCT00116818

Brief Summary

The purpose of this study is to assess the effect of an aqueous nasal spray investigational compound compared to placebo on the hypothalamic pituitary adrenocortical (HPA) axis system in adolescents and adults 12 to 65 years of age with perennial allergic rhinitis. This study can last up to 6 weeks and you will come to the clinic up to 7 times. Clinic visits include physical examinations, vital sign assessments, clinical laboratory assessments, ECGs and allergy skin testing. You will need to complete a daily diary card and spend the night in the clinic on 2 occasions to collect urine and blood samples over 24 hour periods.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

June 30, 2005

Last Update Submit

September 13, 2016

Conditions

Rhinitis, Allergic, Perennial

Keywords

perennial allergic rhinitisintranasal corticosteroidHPA axis functionGW685698X

Outcome Measures

Primary Outcomes (1)

  • HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

Secondary Outcomes (1)

  • Results of adverse event, laboratory, nasal examination, vital sign, ECG and pharmacokinetic assessments.

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: GW685698X aqueous nasal spray

Interventions

GW685698X aqueous nasal sprayDRUG
Arm 1

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis and history of perennial allergic rhinitis.
  • Must be willing to stay overnight in the clinic at the beginning and end of the study for the collection of urine and blood samples over 24 hours.
  • Must comply with all study procedures and be literate.

You may not qualify if:

  • Use of tobacco products.
  • Work a rotating shift.
  • Significant concurrent medical conditions.
  • Certain medications such as corticosteroids and allergy medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Mississauga, Ontario, L4W 1N2, Canada

Location

Related Publications (3)

  • Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on hypothalamic-pituitary-adrenal (HPA) axis function by once-daily fluticasone furoate* nasal spray (FFNS) 110 mcg in adolescents and adults with perennial allergic rhinitis (PAR).

    RESULT

  • Patel P, Ratner P, Clements D, Wu W, Philpot E. Twenty-four hour serum and urine cortisol data support hypothalamic-pituitary adrenocortical axis safety of once-daily fluticasone furoate*nasal spray 110mcg in adolescents and adults with perennial allerg

    RESULT

  • Patel D, Ratner P, Clements D, Wu W, Faris M, Philpot E. Lack of effect on adult and adolescent hypothalamic-pituitary-adrenal axis function with use of fluticasone furoate nasal spray. Ann Allergy Asthma Immunol. 2008 May;100(5):490-6. doi: 10.1016/S1081-1206(10)60476-0.

    PMID: 18517083DERIVED

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

January 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

September 15, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Study Protocol (FFR20002)Access
Dataset Specification (FFR20002)Access
Annotated Case Report Form (FFR20002)Access
Statistical Analysis Plan (FFR20002)Access
Clinical Study Report (FFR20002)Access
Individual Participant Data Set (FFR20002)Access
Informed Consent Form (FFR20002)Access

Locations

CA(1)US(1)