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Study Of Adults And Adolescents With Vasomotor Rhinitis

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ClinicalTrials.gov Identifier: NCT00117325
Recruitment Status : Completed
First Posted : July 6, 2005
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 6, 2005
Results First Submitted Date  ICMJE August 11, 2017
Results First Posted Date  ICMJE March 13, 2018
Last Update Posted Date March 13, 2018
Actual Study Start Date  ICMJE July 11, 2005
Actual Primary Completion Date February 9, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2017)
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
Mean change from baseline in daily, reflective total nasal symptom scores.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Number of Participants With Overall Evaluation of Response to Therapy [ Time Frame: Up to 4 weeks ]
    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.
  • Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • 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 [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and up to Week 4 ]
    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).
  • Mean Scores Changes From Baseline as a Function of Time [ Time Frame: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
  • Mean change from baseline in AM, pre-dose, instantaneous total nasal symptom scores.
  • Overall evaluation of response to therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Adults And Adolescents With Vasomotor Rhinitis
Official Title  ICMJE A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Vasomotor
Intervention  ICMJE Drug: GW685698X
Aqueous Nasal Spray 100mcg
Study Arms  ICMJE Experimental: GW685698X
GW685698X
Intervention: Drug: GW685698X
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2017)
352
Original Enrollment  ICMJE
 (submitted: June 30, 2005)
350
Actual Study Completion Date  ICMJE February 9, 2006
Actual Primary Completion Date February 9, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Germany,   Norway,   Romania,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00117325
Other Study ID Numbers  ICMJE FFR30006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP