Trial · NCT00609674
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
NCT00609674, Phase 4, Completed, GlaxoSmithKline; results first posted 2009-12-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis. Trials, record NCT00609674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00609674
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
- NCT number
- NCT00609674
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 315 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Fluticasone furoate nasal spray, Placebo
- First posted
- 2008-02-07
- Last updated
- 2016-12-16
- Results first posted
- 2009-12-23
Source ClinicalTrials.gov
Registered outcomes15
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 Scores (rTNSS) | Daily; Baseline through End of Study (Week 4) | TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS (performed in the morning \[AM\] and evening \[PM\]) was a rating of the severity of symptoms over the previous 12 hours. The daily rTNSS was the average of the AM rTNSS and PM rTNSS assessments. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) | Daily; Baseline through End of Study (Week 4) | The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Change from baseline is calculated as the score over the entire treatment period minus the score at baseline. TNSS: Total possible score ranges from 0 to 12. |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) | Daily; Baseline through End of Study (Week 4) | The TOSS is equal to the sum of the three individual ocular symptom scores for eye itching/burning, eye tearing/watering, and eye redness, where each symptom is scored on a scale of 0 (none) to 3 (severe); total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS | Daily; Baseline through End of Study (Week 4) | TNSS = the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS (performed in the morning \[AM\] and evening \[PM\]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS | Daily; Baseline through End of Study (Week 4) | TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 \[none\] to 3 \[severe\]; total possible score of 0 to 12). The rTNSS (performed in the morning \[AM\] and evening \[PM\]) is a rating of the severity of symptoms over the previous 12 hours. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS | Daily; Baseline through End of Study (Week 4) | The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). AM, pre-dose iTNSS: sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score range of 0 to 12. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing | Daily; Baseline through End of Study (Week 4) | The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). The AM, pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed immediately prior to taking the daily dose. Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12. |
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing. | Daily; Baseline through End of Study (Week 4) | The rTNSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTNSS) and PM (PM rTNSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 12. |
| Secondary | Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | Daily; Baseline through End of Study (Week 4) | The AM, pre-dose iTOSS is the sum of the 3 individual ocular symptom scores for eyes itching/burning, eyes tearing/watering, and eye redness, performed immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. Change from baseline is calculated as the score at the end of study minus the score at baseline. |
| Secondary | Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS | Daily; Baseline through End of Study (Week 4) | The rTOSS is a rating of the severity of symptoms over the previous 12 hours and was performed in the AM (AM rTOSS) and PM (PM rTOSS). Change from baseline is calculated as the score at the end of study minus the score at baseline. Each symptom is scored on a scale of 0 (none) to 3 (severe), with a total possible score of 0 to 9. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Daily; Baseline through End of Study (Week 4) | Intent-to-Treat (ITT) Population: all randomized subjects who received at least one dose of study drug | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Nasal Symptoms: Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS and AM, Pre-dose iTNSS | Daily; Baseline through End of Study (Week 4) | ITT Population | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Individual Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Individual Daily Reflective Nasal Symptom Scores and AM, Pre-dose Instantaneous Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the Entire Treatment Period in Both Individual AM Reflective and PM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing. | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM, Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS) | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Total Ocular Symptoms: Mean Change From Baseline Over the Entire Treatment Period in Both the AM Reflective Total Ocular Symptom Scores (rTOSS) and PM rTOSS | Daily; Baseline through End of Study (Week 4) | ITT Population | Points on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group88
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 Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) | Placebo | -2.29 | Standard Error 0.25 | Points on a scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) | Fluticasone Furoate 110 mcg | -2.97 | Standard Error 0.24 | Points on a scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) | Placebo | -1.99 | Standard Error 0.20 | Points on a scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Ocular Symptom Scores (rTOSS) | Fluticasone Furoate 110 mcg | -2.23 | Standard Error 0.19 | Points on a scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Placebo | -2.45 | Standard Error 0.24 | Points on a scale | |
| Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS) | Fluticasone Furoate 110 mcg | -3.19 | Standard Error 0.23 | Points on a scale | |
| Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS | Placebo | -2.40 | Standard Error 0.24 | Points on a scale | |
| Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in AM rTNSS | Fluticasone Furoate 110 mcg | -3.15 | Standard Error 0.23 | Points on a scale | |
| Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS | Placebo | -2.51 | Standard Error 0.25 | Points on a scale | |
| Total Nasal Symptoms: Mean Change From Baseline Over the Entire Treatment Period in PM rTNSS | Fluticasone Furoate 110 mcg | -3.26 | Standard Error 0.24 | Points on a scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 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 | 155 | |
| Overall Study | STARTED | Fluticasone Furoate 110 mcg | 160 | |
| Overall Study | COMPLETED | Placebo | 148 | |
| Overall Study | COMPLETED | Fluticasone Furoate 110 mcg | 153 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate 110 mcg | 7 |
Source ClinicalTrials.gov
Adverse events6
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 | 13 | 155 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Fluticasone Furoate 110 mcg | 24 | 160 | |
| other | Headache | Nervous system disorders | Placebo | 9 | 155 | |
| other | Headache | Nervous system disorders | Fluticasone Furoate 110 mcg | 8 | 160 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 2 | 155 | |
| other | Nasopharyngitis | Infections and infestations | Fluticasone Furoate 110 mcg | 8 | 160 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Fluticasone Furoate 110 mcg | ||
| Total, other adverse events | Placebo | 22 | 155 |
| Total, other adverse events | Fluticasone Furoate 110 mcg | 24 | 160 |
| Total, serious adverse events | Placebo | 0 | 155 |
| Total, serious adverse events | Fluticasone Furoate 110 mcg | 0 | 160 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21144223 | BACKGROUND |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluticasone Furoate 110 mcg vs Placebo: serious adverse events |
Source 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/NCT00609674
GET https://conductscience.org/api/trials/v1/NCT00609674/results?page=2