Trial · NCT02424539
A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
NCT02424539, Phase 4, Completed, GlaxoSmithKline; results first posted 2019-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR). Trials, record NCT02424539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02424539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
- NCT number
- NCT02424539
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 358 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rhinitis, Allergic, Perennial and Seasonal, Rhinitis, Allergic
- Interventions
- FFNS, Placebo
- First posted
- 2015-04-23
- Last updated
- 2021-01-11
- Results first posted
- 2019-02-06
Source ClinicalTrials.gov
Registered outcomes19
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) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Secondary | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Week 2 | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. |
| Secondary | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | Baseline and up to Week 2 | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. |
| Secondary | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | Baseline and up to Week 2 | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value |
| Secondary | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Secondary | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Secondary | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Week 4 | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. |
| Secondary | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | Baseline and up to Week 4 | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. |
| Secondary | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Secondary | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | Baseline and up to Week 4 | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Week 2 | ITT Population | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | Baseline and up to Week 2 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | Baseline and up to Week 2 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | ITT Population | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Week 4 | ITT Population | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | Baseline and up to Week 4 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | Baseline and up to Week 4 | ITT Population | Days | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group297
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) Over the First 2 Weeks Treatment Period | Placebo | -1.95 | Standard Error 0.16 | Scores on a scale | |
| Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | FF 55 µg QD | -3.18 | Standard Error 0.16 | Scores on a scale | |
| Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | FF 110 µg QD | -3.28 | Standard Error 0.16 | Scores on a scale | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Placebo | Significantly improved | 13 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | FF 55 µg QD | Significantly improved | 38 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | FF 110 µg QD | Significantly improved | 51 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Placebo | Moderately improved | 30 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | FF 55 µg QD | Moderately improved | 48 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | FF 110 µg QD | Moderately improved | 33 | Participants | |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Placebo | Mildly improved | 45 | Participants |
1 to 10 of 297Source ClinicalTrials.gov
See all 297 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 120 | |
| Overall Study | STARTED | FF 55 µg QD | 119 | |
| Overall Study | STARTED | FF 110 µg QD | 119 | |
| Overall Study | COMPLETED | Placebo | 106 | |
| Overall Study | COMPLETED | FF 55 µg QD | 111 | |
| Overall Study | COMPLETED | FF 110 µg QD | 111 | |
| Overall Study | NOT COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | FF 55 µg QD | 8 | |
| Overall Study | NOT COMPLETED | FF 110 µg QD | 8 |
Source ClinicalTrials.gov
Adverse events240
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 | Upper respiratory tract infection | Infections and infestations | Placebo | 15 | 120 | |
| other | Upper respiratory tract infection | Infections and infestations | FF 55 µg QD | 26 | 119 | |
| other | Upper respiratory tract infection | Infections and infestations | FF 110 µg QD | 19 | 119 | |
| other | Sinusitis | Infections and infestations | Placebo | 1 | 120 | |
| other | Sinusitis | Infections and infestations | FF 55 µg QD | 4 | 119 | |
| other | Sinusitis | Infections and infestations | FF 110 µg QD | 1 | 119 | |
| other | Tonsillitis | Infections and infestations | Placebo | 1 | 120 | |
| other | Tonsillitis | Infections and infestations | FF 55 µg QD | 2 | 119 | |
| other | Tonsillitis | Infections and infestations | FF 110 µg QD | 2 | 119 | |
| other | Bronchitis | Infections and infestations | Placebo | 2 | 120 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 120 |
| Total, all-cause mortality | FF 55 µg QD | 0 | 119 |
| Total, all-cause mortality | FF 110 µg QD | 0 | 119 |
| Total, other adverse events | Placebo | 51 | 120 |
| Total, other adverse events | FF 55 µg QD | 52 | 119 |
| Total, other adverse events | FF 110 µg QD | 65 | 119 |
| Total, serious adverse events | Placebo | 0 | 120 |
| Total, serious adverse events | FF 55 µg QD | 0 | 119 |
| Total, serious adverse events | FF 110 µg QD | 1 | 119 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33007780 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02424539
GET https://conductscience.org/api/trials/v1/NCT02424539/results?page=2