Trial · NCT01231464

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis

NCT01231464, Phase 3, Completed, GlaxoSmithKline; results first posted 2011-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis. Trials, record NCT01231464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231464

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis
NCT number: NCT01231464
Status: Completed
Phases: Phase 3
Enrollment: 365 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Rhinitis, Allergic, Perennial, Allergic Rhinitis
Interventions: fluticasone furoate nasal spray, placebo
First posted: 2010-11-01
Last updated: 2017-07-06
Results first posted: 2011-02-04

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 Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)	Baseline through entire treatment period (Day 1 through Day 14)	The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.
Secondary	Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.
Secondary	Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.

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 Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)	Baseline through entire treatment period (Day 1 through Day 14)	Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.	Points on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.	Points on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living	Baseline through end of study (Day 1 through Day 15/Early Withdrawal)	FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.	Points on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)	FFNS 110 mcg	-4.226	Standard Error 0.1646	Points on a scale
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)	Placebo	-2.728	Standard Error 0.1656	Points on a scale
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	FFNS 110 mcg	-4.2	Standard Error 0.22	Points on a scale
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	Placebo	-2.9	Standard Error 0.22	Points on a scale
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living	FFNS 110 mcg	-1.2	Standard Error 0.07	Points on a scale
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living	Placebo	-0.8	Standard Error 0.07	Points on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	FFNS 110 mcg	182
Overall Study	STARTED	Placebo	183
Overall Study	COMPLETED	FFNS 110 mcg	177
Overall Study	COMPLETED	Placebo	176
Overall Study	NOT COMPLETED	FFNS 110 mcg	5
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events36

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
other	Upper respiratory tract infection	Infections and infestations	FFNS 110 mcg	4	181
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	182
other	Nasopharyngitis	Infections and infestations	FFNS 110 mcg	0	181
other	Nasopharyngitis	Infections and infestations	Placebo	3	182
other	Oral herpes	Infections and infestations	FFNS 110 mcg	1	181
other	Oral herpes	Infections and infestations	Placebo	0	182
other	Cough	Respiratory, thoracic and mediastinal disorders	FFNS 110 mcg	2	181
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	0	182
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	FFNS 110 mcg	2	181
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Placebo	0	182

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FFNS 110 mcg
Total, all-cause mortality	Placebo
Total, other adverse events	FFNS 110 mcg	13	181
Total, other adverse events	Placebo	9	182
Total, serious adverse events	FFNS 110 mcg	0	181
Total, serious adverse events	Placebo	0	182

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21888757	DERIVED

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
FFNS 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01231464

GET https://conductscience.org/api/trials/v1/NCT01231464/events?page=2

API reference For AI assistants