Trial · NCT00682643

A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis

NCT00682643, Phase 4, Completed, GlaxoSmithKline; results first posted 2012-03-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis. Trials, record NCT00682643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00682643

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Trial

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

Title: A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis
NCT number: NCT00682643
Status: Completed
Phases: Phase 4
Enrollment: 550 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Rhinitis, Allergic, Perennial
Interventions: fluticasone furoate nasal spray, vehicle placebo nasal spray
First posted: 2008-05-22
Last updated: 2017-01-13
Results first posted: 2012-03-13

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104	An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in Lens Opacities Classification System, Version III (LOCS III; system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Data represent the Kaplan-Meier estimate for the CU of par. with an event of P based on a lifetest table.
Primary	Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event	Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104	An event for IOP is defined as an increase of 7 millimeters of mercury (mm Hg) or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry (GAT). GAT is a commonly used method of determining approximate intraocular pressure. The data below represent the Kaplan-Meier estimate for the cumulative proportion of participants with an IOP event based on a lifetest table.
Secondary	Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104	Baseline, Week 52, and Week 104	An event for P (opacity in the lens positioned just anterior to the posterior lens capsule and characterized by the posterior migration of lens epithelial cells from the lens bow) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Secondary	Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104	Baseline, Week 52, and Week 104	An event for P is defined as an increase of \>=0.3 from baseline in LOCS III (classification system based on standard color photographic transparencies) grade for P (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Secondary	Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104	Baseline, Week 52, and Week 104	An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Secondary	Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104	Baseline, Week 52, and Week 104	An event for C (an opacity starting at the outer edge of the lens and progressing toward the center) is defined as an increase of \>=0.3 from baseline in LOCS III (system used for the grading and comparison of cataract severity and type based on standard color photographic transparencies) grade for C (range=0.1 \[lens clear\] to 5.9 \[lens unclear\]), in either eye. Change from baseline was calculated by subtracting the baseline value from the Week 52 and Week 104 value.
Secondary	Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104	Baseline, Week 52, and Week 104	Nuclear opacity refers to the opacity in the central nucleus of the eye.The range for NO is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NO was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Secondary	Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104	Baseline, Week 52, and Week 104	Nuclear color is associated with the force required to compress a lens to 75% of its original depth. The range for NC is 0.1 (no opacity) to 6.9 (maximum opacity). Change from baseline in NC was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Secondary	Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104	Baseline, Week 52, and Week 104	An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 or Week 104 value.
Secondary	Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52	Baseline and Week 52	An event for IOP is defined as an increase of 7 mm Hg or greater from baseline in IOP, in either eye, using Goldmann Applanation Tonometry. Participants without post-baseline ophthalmic exam data were censored at the randomization date. Change from baseline was calculated by subtracting the baseline value from the Week 52 value.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104	ITT Population. All participants (par.) with post-baseline ophthalmic examination data were included in the analysis for this endpoint. Par. without post-baseline ophthalmic exam data were censored at the randomization data. Par. who completed the study without an event for P or were discontinued for reasons other than an event for P were censored.	Percentage of participants	NUMBER
PRIMARY	Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event	Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104	ITT Population. All participants with post-baseline ophthalmic examination data were included in the analysis for this endpoint.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	scores on a scale	MEAN
SECONDARY	Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	participants	NUMBER
SECONDARY	Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	scores on a scale	MEAN
SECONDARY	Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	participants	NUMBER
SECONDARY	Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104	Baseline, Week 52, and Week 104	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	mm Hg	MEAN
SECONDARY	Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52	Baseline and Week 52	ITT Population. The number analyzed reflects those participants remaining in the study and contributing data at the indicated time points.	participants	NUMBER

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group430

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

Outcome	Group	Category	Value	Units
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Placebo	Week 12	0.60	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	FF 110 mcg QD	Week 12	0.88	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Placebo	Week 24	1.24	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	FF 110 mcg QD	Week 24	1.84	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Placebo	Week 36	1.93	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	FF 110 mcg QD	Week 36	2.56	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Placebo	Week 52	2.68	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	FF 110 mcg QD	Week 52	3.72	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	Placebo	Week 64	2.68	Percentage of participants
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)	FF 110 mcg QD	Week 64	3.72	Percentage of participants

1 to 10 of 430Source ClinicalTrials.gov

See all 430 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	182
Overall Study	STARTED	FF 110 mcg QD	368
Overall Study	COMPLETED	Placebo	104
Overall Study	COMPLETED	FF 110 mcg QD	199
Overall Study	NOT COMPLETED	Placebo	78
Overall Study	NOT COMPLETED	FF 110 mcg QD	169

Source ClinicalTrials.gov

Adverse events70

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	Epistaxis	Respiratory, thoracic and mediastinal disorders	Placebo	34	181
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	FF 110 mcg QD	123	367
other	Sinusitis	Infections and infestations	Placebo	31	181
other	Sinusitis	Infections and infestations	FF 110 mcg QD	47	367
other	Upper respiratory tract infection	Infections and infestations	Placebo	29	181
other	Upper respiratory tract infection	Infections and infestations	FF 110 mcg QD	52	367
other	Nasopharyngitis	Infections and infestations	Placebo	17	181
other	Nasopharyngitis	Infections and infestations	FF 110 mcg QD	44	367
other	Influenza	Infections and infestations	Placebo	16	181
other	Influenza	Infections and infestations	FF 110 mcg QD	25	367

1 to 10 of 70Source ClinicalTrials.gov

See all 70 adverse events

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	FF 110 mcg QD
Total, other adverse events	Placebo	97	181
Total, other adverse events	FF 110 mcg QD	232	367
Total, serious adverse events	Placebo	7	181
Total, serious adverse events	FF 110 mcg QD	12	367

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23806459	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
FF 110 mcg QD 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.

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