Trial · NCT00117325
Study Of Adults And Adolescents With Vasomotor Rhinitis
NCT00117325, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Adults And Adolescents With Vasomotor Rhinitis. Trials, record NCT00117325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00117325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Adults And Adolescents With Vasomotor Rhinitis
- NCT number
- NCT00117325
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 352 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Vasomotor
- Interventions
- GW685698X
- First posted
- 2005-07-06
- Last updated
- 2018-03-13
- Results first posted
- 2018-03-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | 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). |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | 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). |
| Secondary | Number of Participants With Overall Evaluation of Response to Therapy | 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. |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS | 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). |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS | 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). |
| Secondary | Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS | 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). |
| Secondary | Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS | 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). |
| 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 | 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). |
| 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 | 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). |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Overall Evaluation of Response to Therapy | Up to 4 weeks | RITT population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT population. Only those participants with data available at the indicated time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the indicated time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the indicated time points were analyzed. | Percent change in score | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the indicated time points were analyzed. | Percent change in score | LEAST_SQUARES_MEAN |
| 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 | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the specified time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
| 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 | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the specified time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip | Baseline (4 days prior to randomization [Day 1]) and up to Week 4 | RITT Population. Only those participants with data available at the specified time points were analyzed. | Score on scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group274
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | Placebo | -1.71 | Standard Error 0.16 | Score on scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) | Fluticasone Furoate 110 mcg QD | -2.05 | Standard Error 0.15 | Score on scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | Placebo | -1.48 | Standard Error 0.16 | Score on scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) | Fluticasone Furoate 110 mcg QD | -1.87 | Standard Error 0.16 | Score on scale | |
| Number of Participants With Overall Evaluation of Response to Therapy | Placebo | Significantly Improved | 26 | Participants | |
| Number of Participants With Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 mcg QD | Significantly Improved | 33 | Participants | |
| Number of Participants With Overall Evaluation of Response to Therapy | Placebo | Moderately Improved | 37 | Participants | |
| Number of Participants With Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 mcg QD | Moderately Improved | 40 | Participants | |
| Number of Participants With Overall Evaluation of Response to Therapy | Placebo | Mildly Improved | 45 | Participants | |
| Number of Participants With Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 mcg QD | Mildly Improved | 47 | Participants |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 173 | |
| Overall Study | STARTED | Fluticasone Furoate 110 mcg QD | 179 | |
| Overall Study | COMPLETED | Placebo | 160 | |
| Overall Study | COMPLETED | Fluticasone Furoate 110 mcg QD | 167 | |
| Overall Study | NOT COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate 110 mcg QD | 12 |
Source ClinicalTrials.gov
Adverse events192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo | 23 | 173 | |
| other | Headache | Nervous system disorders | Fluticasone Furoate 110mcg QD | 12 | 179 | |
| other | Sinus headache | Nervous system disorders | Placebo | 3 | 173 | |
| other | Sinus headache | Nervous system disorders | Fluticasone Furoate 110mcg QD | 2 | 179 | |
| other | Migraine | Nervous system disorders | Placebo | 0 | 173 | |
| other | Migraine | Nervous system disorders | Fluticasone Furoate 110mcg QD | 2 | 179 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 173 | |
| other | Dizziness | Nervous system disorders | Fluticasone Furoate 110mcg QD | 0 | 179 | |
| other | Paraesthesia | Nervous system disorders | Placebo | 1 | 173 | |
| other | Paraesthesia | Nervous system disorders | Fluticasone Furoate 110mcg QD | 0 | 179 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 173 |
| Total, all-cause mortality | Fluticasone Furoate 110mcg QD | 0 | 179 |
| Total, other adverse events | Placebo | 65 | 173 |
| Total, other adverse events | Fluticasone Furoate 110mcg QD | 61 | 179 |
| Total, serious adverse events | Placebo | 0 | 173 |
| Total, serious adverse events | Fluticasone Furoate 110mcg QD | 0 | 179 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fluticasone Furoate 110mcg QD vs Placebo: deaths from any cause | Trial comparisons |
| Fluticasone Furoate 110mcg QD vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00117325
GET https://conductscience.org/api/trials/v1/NCT00117325/results?page=2