Clinical Trials Logo
  1. Home
  2. Rhinitis, Allergic, Perennial
  3. NCT00103454
  4. Details
NCT00103454 Clinical Trial

A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).

Rhinitis, Allergic, Perennial Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00103454
Other study ID # FFR30002
Secondary ID
Status Completed
Phase Phase 3
First received February 8, 2005
Last updated September 15, 2016
Start date January 2005
Est. completion date May 2005

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

Clinical Trial Summary

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Description:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)

Recruitment information / eligibility
Status Completed
Enrollment 288
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion criteria:

- Diagnosis of perennial allergic rhinitis (PAR).

- Must comply with study procedures and be literate.

Exclusion criteria:

- Significant concomitant medical conditions.

- Use of corticosteroids.

- Use of allergy medications and some other medications during the study.

- Current tobacco use.

- Clinically significant abnormal ECG or laboratory abnormality.

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

Intervention

Drug:
• GW685698X

Locations
Country Name City State
Canada GSK Investigational Site Kelowna British Columbia
Canada GSK Investigational Site Mississauga Ontario
Canada GSK Investigational Site Ottawa Ontario
Canada GSK Investigational Site Québec Quebec
Canada GSK Investigational Site Saskatoon Saskatchewan
Canada GSK Investigational Site Vancouver British Columbia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Baltimore Maryland
United States GSK Investigational Site Canton Ohio
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Colorado Springs Colorado
United States GSK Investigational Site Eugene Oregon
United States GSK Investigational Site Lake Oswego Oregon
United States GSK Investigational Site Lawrenceville Georgia
United States GSK Investigational Site Lilburn Georgia
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Los Angeles California
United States GSK Investigational Site Medford Oregon
United States GSK Investigational Site Metairie Louisiana
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Mission Viejo California
United States GSK Investigational Site Murray Utah
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site New Braunfels Texas
United States GSK Investigational Site North Andover Massachusetts
United States GSK Investigational Site North Dartmouth Massachusetts
United States GSK Investigational Site Ocean New Jersey
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Omaha Nebraska
United States GSK Investigational Site Orange California
United States GSK Investigational Site Orangeburg South Carolina
United States GSK Investigational Site Portland Maine
United States GSK Investigational Site Providence Rhode Island
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Rockville Maryland
United States GSK Investigational Site San Diego California
United States GSK Investigational Site San Diego California
United States GSK Investigational Site South Bend Indiana
United States GSK Investigational Site South Burlington Vermont
United States GSK Investigational Site Springfield Massachusetts
United States GSK Investigational Site St. Louis Missouri
United States GSK Investigational Site St. Louis Missouri
United States GSK Investigational Site Summit New Jersey
United States GSK Investigational Site Tallahassee Florida
United States GSK Investigational Site Tampa Florida
United States GSK Investigational Site Vero Beach Florida
United States GSK Investigational Site West Allis Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy

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. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Secondary Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
See also
  Status Clinical Trial Phase
Completed NCT02443805 - Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR Phase 3
Completed NCT01231464 - A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis Phase 3
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT00224523 - Long Term Safety Of GW685698X Via Nasal Biopsy Phase 3
Completed NCT00658918 - To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405) Phase 3
Completed NCT00404586 - Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber Phase 1
Withdrawn NCT02988778 - Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis Phase 3
Completed NCT00988247 - Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis Phase 3
Completed NCT01644617 - A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627) Phase 2
Completed NCT01678807 - Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008) Phase 1
Completed NCT01216384 - Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers Phase 1
Completed NCT00848965 - A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber Phase 4
Completed NCT00092118 - The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265) Phase 3
Completed NCT00839189 - Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults Phase 1
Completed NCT00570492 - Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study. Phase 4
Completed NCT00806754 - Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490) Phase 4
Recruiting NCT00153595 - EWO1 in Persistent Allergic Rhinitis Patients Phase 2/Phase 3
Completed NCT00132925 - An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis Phase 3
Completed NCT02498509 - Clinical Trial to Evaluate the Efficacy and Safety of CKD-342 Phase 3
Completed NCT01134705 - Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis) Phase 3

External Links