Study Of Adults And Adolescents With Vasomotor Rhinitis

Rhinitis, Vasomotor Clinical Trial

Official title:

A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117325
• Other study ID #: FFR30006
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: March 7, 2018
• Start date: July 11, 2005
• Est. completion date: February 9, 2006

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• 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 vasomotor rhinitis (VMR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: February 9, 2006
• Est. primary completion date: February 9, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion criteria:

• Must be outpatients.

• Diagnosis of VMR.

• Literate in English or native language.

Exclusion criteria:

• Significant concomitant medical condition.

• Use corticosteroids or other allergy medications during the study.

• Used tobacco products within the past year.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Vasomotor

Intervention

Drug:
• GW685698X
Aqueous Nasal Spray 100mcg

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kelowna	British Columbia
Canada	GSK Investigational Site	Québec
Czechia	GSK Investigational Site	Litomerice
Czechia	GSK Investigational Site	Olomouc
Czechia	GSK Investigational Site	Tabor
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Norway	GSK Investigational Site	Larvik
Norway	GSK Investigational Site	Nesttun
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Deva
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Easton	Pennsylvania
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lake Oswego	Oregon
United States	GSK Investigational Site	Liverpool	New York
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mission Viejo	California
United States	GSK Investigational Site	Mount Laurel	New Jersey
United States	GSK Investigational Site	North Olmsted	Ohio
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Palmyra	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rockville	Maryland
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Barbara	California
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Woodstock	Georgia
United States	GSK Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Norway,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)	The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)	The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Number of Participants With Overall Evaluation of Response to Therapy	The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.	Up to 4 weeks
Secondary	Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS	The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS	The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS	The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS	The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip	The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip	The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and up to Week 4
Secondary	Mean Scores Changes From Baseline as a Function of Time	The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).	Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days

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