Trial · NCT01630135
Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
NCT01630135, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-05-01
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ConductScience Library. Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis. Trials, record NCT01630135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01630135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
- NCT number
- NCT01630135
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Fluticasone furoate, Placebo
- First posted
- 2012-06-28
- Last updated
- 2017-01-11
- Results first posted
- 2013-05-01
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline. |
| Secondary | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Baseline; Week 1 and Week 2 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline. |
| Secondary | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100. |
| Secondary | Mean Change From Baseline in 3TNSS at the Indicated Days | Baseline; Days 1 through 14 | The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline. |
| Secondary | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value \* 100. |
| Secondary | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value \* 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Baseline; Week 1 and Week 2 | FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in 3TNSS at the Indicated Days | Baseline; Days 1 through 14 | FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants with BL TOSS \>0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Baseline through the entire treatment period (2 weeks), Week 1, and Week 2 | FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex. | Percent change | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group248
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 the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | Fluticasone Furoate 55 µg Per Day | -1.98 | Standard Error 0.12 | Scores on a scale | |
| Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period | Placebo | -0.89 | Standard Error 0.12 | Scores on a scale | |
| Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Fluticasone Furoate 55 µg Per Day | Week 1, n=131, 130 | -1.60 | Standard Error 0.12 | Scores on a scale |
| Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Placebo | Week 1, n=131, 130 | -0.70 | Standard Error 0.12 | Scores on a scale |
| Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Fluticasone Furoate 55 µg Per Day | Week 2, n=131, 128 | -2.38 | Standard Error 0.13 | Scores on a scale |
| Mean Change From Baseline in 3TNSS at Week 1 and Week 2 | Placebo | Week 2, n=131, 128 | -1.10 | Standard Error 0.13 | Scores on a scale |
| Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Fluticasone Furoate 55 µg Per Day | Entire treatment period, n=131, 130 | -39.76 | Standard Error 2.38 | Percent change |
| Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Placebo | Entire treatment period, n=131, 130 | -17.74 | Standard Error 2.36 | Percent change |
| Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Fluticasone Furoate 55 µg Per Day | Week 1, n=131, 130 | -31.96 | Standard Error 2.46 | Percent change |
| Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 | Placebo | Week 1, n=131, 130 | -13.89 | Standard Error 2.44 | Percent change |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluticasone Furoate 55 µg Per Day | 131 | |
| Overall Study | STARTED | Placebo | 130 | |
| Overall Study | COMPLETED | Fluticasone Furoate 55 µg Per Day | 131 | |
| Overall Study | COMPLETED | Placebo | 128 | |
| Overall Study | NOT COMPLETED | Fluticasone Furoate 55 µg Per Day | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events72
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 | Nasopharyngitis | Infections and infestations | Fluticasone Furoate 55 µg Per Day | 6 | 131 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 130 | |
| other | Bronchitis | Infections and infestations | Fluticasone Furoate 55 µg Per Day | 1 | 131 | |
| other | Bronchitis | Infections and infestations | Placebo | 1 | 130 | |
| other | Acute sinusitis | Infections and infestations | Fluticasone Furoate 55 µg Per Day | 1 | 131 | |
| other | Acute sinusitis | Infections and infestations | Placebo | 0 | 130 | |
| other | Conjunctivitis bacterial | Infections and infestations | Fluticasone Furoate 55 µg Per Day | 1 | 131 | |
| other | Conjunctivitis bacterial | Infections and infestations | Placebo | 0 | 130 | |
| other | Hand-foot-and-mouth disease | Infections and infestations | Fluticasone Furoate 55 µg Per Day | 1 | 131 | |
| other | Hand-foot-and-mouth disease | Infections and infestations | Placebo | 0 | 130 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluticasone Furoate 55 µg Per Day | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Fluticasone Furoate 55 µg Per Day | 23 | 131 |
| Total, other adverse events | Placebo | 25 | 130 |
| Total, serious adverse events | Fluticasone Furoate 55 µg Per Day | 0 | 131 |
| Total, serious adverse events | Placebo | 0 | 130 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluticasone Furoate 55 µg Per Day 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.
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