Trial · NCT00289198
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
NCT00289198, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-04-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR). Trials, record NCT00289198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00289198
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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 Perennial Allergic Rhinitis (PAR)
- NCT number
- NCT00289198
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- FF, Placebo
- First posted
- 2006-02-09
- Last updated
- 2018-04-13
- Results first posted
- 2018-04-13
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks | Baseline (Day 1) and up to Week 6 | 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 is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received \>=1 dose of study drug. Only those participants available at the specified time points were analyzed |
| Secondary | Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period | Baseline (Day 1) and up to Week 6 | 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 individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed. |
| Secondary | Number of Participants With Response to Therapy Over Entire Treatment Period | Up to 6 weeks | Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo. |
| Secondary | Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | 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 AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed. |
| Secondary | Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | 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 PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed. |
| Secondary | Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | 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 is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received \>=1 dose of study drug. Only those participants available at the specified time points were analyzed |
| Secondary | Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period | Baseline and up to 6 weeks | 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 is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value\*100. |
| Secondary | Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. |
| Secondary | Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed. |
| Secondary | Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment | Baseline (Day 1) and up to 6 weeks | INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 \[none\] to 3 \[severe\]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks | Baseline (Day 1) and up to Week 6 | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period | Baseline (Day 1) and up to Week 6 | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Response to Therapy Over Entire Treatment Period | Up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period | Baseline and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | ITT population. Only those participants available at the time of assessment were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period | Baseline (Day 1) and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment | Baseline (Day 1) and up to 6 weeks | ITT population. Data is presented for the participants available at the time of assessment. | Scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group96
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 (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks | Placebo | -2.69 | Standard Error 0.18 | Scores on a scale | |
| Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks | Fluticasone Furoate | -3.95 | Standard Error 0.18 | Scores on a scale | |
| Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period | Placebo | -2.36 | Standard Error 0.18 | Scores on a scale | |
| Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period | Fluticasone Furoate | -3.82 | Standard Error 0.18 | Scores on a scale | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Placebo | Significantly Improved | 21 | Participants | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Fluticasone Furoate | Significantly Improved | 56 | Participants | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Placebo | Moderately Improved | 38 | Participants | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Fluticasone Furoate | Moderately Improved | 37 | Participants | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Placebo | Mildly Improved | 37 | Participants | |
| Number of Participants With Response to Therapy Over Entire Treatment Period | Fluticasone Furoate | Mildly Improved | 31 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 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 | 151 | |
| Overall Study | STARTED | Fluticasone Furoate | 151 | |
| Overall Study | COMPLETED | Placebo | 120 | |
| Overall Study | COMPLETED | Fluticasone Furoate | 121 | |
| Overall Study | NOT COMPLETED | Placebo | 31 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate | 30 |
Source ClinicalTrials.gov
Adverse events208
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 | 29 | 151 | |
| other | Headache | Nervous system disorders | Fluticasone Furoate | 27 | 151 | |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 151 | |
| other | Dizziness | Nervous system disorders | Fluticasone Furoate | 4 | 151 | |
| other | Sinus headache | Nervous system disorders | Placebo | 2 | 151 | |
| other | Sinus headache | Nervous system disorders | Fluticasone Furoate | 1 | 151 | |
| other | Migraine | Nervous system disorders | Placebo | 2 | 151 | |
| other | Migraine | Nervous system disorders | Fluticasone Furoate | 0 | 151 | |
| other | Dysgeusia | Nervous system disorders | Placebo | 1 | 151 | |
| other | Dysgeusia | Nervous system disorders | Fluticasone Furoate | 0 | 151 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 151 |
| Total, all-cause mortality | Fluticasone Furoate | 0 | 151 |
| Total, other adverse events | Placebo | 66 | 151 |
| Total, other adverse events | Fluticasone Furoate | 77 | 151 |
| Total, serious adverse events | Placebo | 0 | 151 |
| Total, serious adverse events | Fluticasone Furoate | 1 | 151 |
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 vs Placebo: deaths from any cause | Trial comparisons |
| Fluticasone Furoate 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/NCT00289198
GET https://conductscience.org/api/trials/v1/NCT00289198/registered?page=2