Trial · NCT00118703
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
NCT00118703, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis. Trials, record NCT00118703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00118703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis
- NCT number
- NCT00118703
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 350 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Vasomotor Rhinitis, Rhinitis, Vasomotor
- Interventions
- GW685698X
- First posted
- 2005-07-12
- Last updated
- 2017-08-21
- Results first posted
- 2017-05-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Baseline 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 (total score 0-9). 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 was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \[PM\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline. |
| Secondary | Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | Baseline and up to Week 4 | The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). 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 Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value. |
| Secondary | Number of Participants Based on Overall Evaluation of Response to Therapy | Week 4 (Day 29) or Early Withdrawal | Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR 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. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period. |
Source ClinicalTrials.gov
Outcomes3
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 in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Baseline and up to Week 4 | Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | Baseline and up to Week 4 | ITT population. Only participants available at the specified timepoint were analyzed. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Based on Overall Evaluation of Response to Therapy | Week 4 (Day 29) or Early Withdrawal | ITT Population. Only participants available at the specified time point were analyzed. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Placebo | -2.11 | Standard Error 0.15 | Score on a scale | |
| Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Fluticasone Furoate 110 µg QD | -2.01 | Standard Error 0.15 | Score on a scale | |
| Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | Placebo | -1.65 | Standard Error 0.14 | Score on a scale | |
| Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS) | Fluticasone Furoate 110 µg QD | -1.59 | Standard Error 0.14 | Score on a scale | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Placebo | Significantly Improved | 20 | Participants | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 µg QD | Significantly Improved | 28 | Participants | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Placebo | Moderately Improved | 39 | Participants | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 µg QD | Moderately Improved | 41 | Participants | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Placebo | Mildly Improved | 42 | Participants | |
| Number of Participants Based on Overall Evaluation of Response to Therapy | Fluticasone Furoate 110 µg QD | Mildly Improved | 43 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 µg QD | 174 | |
| Overall Study | COMPLETED | Placebo | 168 | |
| Overall Study | COMPLETED | Fluticasone Furoate 110 µg QD | 165 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate 110 µg QD | 9 |
Source ClinicalTrials.gov
Adverse events16
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 | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 173 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Fluticasone Furoate 110 µg QD | 12 | 174 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 173 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Fluticasone Furoate 110 µg QD | 4 | 174 | |
| other | Headache | Nervous system disorders | Placebo | 16 | 173 | |
| other | Headache | Nervous system disorders | Fluticasone Furoate 110 µg QD | 14 | 174 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 173 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluticasone Furoate 110 µg QD | 4 | 174 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 173 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Fluticasone Furoate 110 µg QD | 1 | 174 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 110 µg QD | 0 | 174 |
| Total, other adverse events | Placebo | 38 | 173 |
| Total, other adverse events | Fluticasone Furoate 110 µg QD | 42 | 174 |
| Total, serious adverse events | Placebo | 0 | 173 |
| Total, serious adverse events | Fluticasone Furoate 110 µg QD | 1 | 174 |
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 110 µg QD vs Placebo: deaths from any cause | Trial comparisons |
| Fluticasone Furoate 110 µg 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/NCT00118703
GET https://conductscience.org/api/trials/v1/NCT00118703/registered