A Phase 4 interventional study of fluticasone furoate nasal spray and vehicle placebo nasal spray in Rhinitis, Allergic, Perennial, sponsored by GlaxoSmithKline. Completed at 56 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 550 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects eligible for enrollment in the study must meet all of the following criteria:
Subject has provided an appropriately signed and dated informed consent. An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
Subject is treatable on an outpatient basis.
12 years of age and older at Visit 2
To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
Estrogenic vaginal ring. A urine pregnancy test will be done at the screening visit to confirm females of childbearing potential are not pregnant upon entry into the study. In addition, urine pregnancy tests will be done for all females of childbearing potential at each clinic visit.
A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1.
A positive skin test is defined as a wheal ³3mm larger than the diluent control for prick testing.
•Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms could include nasal congestion, rhinorrhea, nasal itching and sneezing.
In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
NOTE: Subjects who meet the above criteria and who also may have seasonal allergic rhinitis (SAR) and/or perennial non-allergic rhinitis (PNAR) are eligible for randomization.
Environment
•Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain, as much as possible, the same environment throughout the study.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Significant concomitant medical conditions, defined as but not limited to:
NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
History of Hepatitis B or C
Inhaled, oral, intramuscular, intravenous, ocular, and/or topical corticosteroids (with the exception of topical hydrocortisone, 1% or less, or equivalent) within 8 weeks prior to Visit 1.
Use of other intranasally administered medications (e.g., Miacalcin)
Known hypersensitivity to corticosteroids or any excipients
Participation in a previous or current FFNS (GW685698X) clinical study
Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco, or has used these products in the last 6 months
Drug: vehicle placebo nasal spray
Drug: fluticasone furoate nasal spray
fluticasone furoate nasal spray
placebo
Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)
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.
Time frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event
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.
Time frame: Baseline; Weeks 12, 24, 36, 52, 64, 76, 88, and 104
Change From Baseline in LOCS III Posterior Subcapsular Opacity at 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.
Time frame: Baseline, Week 52, and Week 104
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
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.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Cortical Opacity (C) at 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.
Time frame: Baseline, Week 52, and Week 104
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
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.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in LOCS III Nuclear Opacity (NO) at 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.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Nuclear Color (NC) at 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.
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 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.
Time frame: Baseline, Week 52, and Week 104
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at 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.
Time frame: Baseline and Week 52
Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at 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 in IOP was calculated by subtracting the baseline value from the Week 104 value.
Time frame: Baseline and Week 104
Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104
ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =\< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the \[decadic\] logarithm of the minimum angle of resolution \[range from +1.00 to -0.30\]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.
Time frame: Baseline, Week 52, and Week 104
Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104
The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the "cup" portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology.
Time frame: Baseline and Week 104
Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods
rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).
Time frame: Baseline, Weeks 1 to 26, Weeks 27 to 52, Weeks 53 to 78, and Weeks 79 to 104
| Milestone | Placebo | FF 110 mcg QD |
|---|---|---|
| Started | 182 | 368 |
| Completed | 104 | 199 |
| Not completed | 78 | 169 |
| Withdrew: Adverse event | 12 | 23 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Protocol violation | 38 | 76 |
| Withdrew: Met protocol-defined stopping criteria | 3 | 4 |
| Withdrew: Lost to follow-up | 1 | 6 |
| Withdrew: Physician decision | 2 | 6 |
| Withdrew: Withdrawal by subject | 19 | 53 |
| Withdrew: Did not receive study drug | 1 | 1 |
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.
| Percentage of participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Week 12 | 0.60 | 0.88 |
| Week 24 | 1.24 | 1.84 |
| Week 36 | 1.93 | 2.56 |
| Week 52 | 2.68 | 3.72 |
| Week 64 | 2.68 | 3.72 |
| Week 76 | 2.68 | 3.72 |
| Week 88 | 2.68 | 4.59 |
| Week 104 | 2.68 | 5.09 |
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.
| percentage of participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Week 12 | 0.00 | 0.00 |
| Week 24 | 0.00 | 0.32 |
| Week 36 | 0.00 | 0.32 |
| Week 52 | 0.00 | 0.71 |
| Week 64 | 0.00 | 1.12 |
| Week 76 | 0.00 | 1.98 |
| Week 88 | 0.84 | 1.98 |
| Week 104 | 0.84 | 2.96 |
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.
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | 0.00 ± 0.042 | 0.00 ± 0.063 |
| Left eye, Week 104; n=104, 198 | 0.00 ± 0.039 | 0.00 ± 0.083 |
| Right eye, Week 52; n=130, 251 | 0.00 ± 0.057 | 0.00 ± 0.061 |
| Right eye, Week 104; n=104, 198 | 0.00 ± 0.042 | -0.01 ± 0.068 |
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.
| participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52, <-0.3; n=130, 251 | 0 | 0 |
| Left eye, Week 52, -0.3; n=130, 251 | 0 | 0 |
| Left eye, Week 52, -0.2; n=130, 251 | 2 | 5 |
| Left eye, Week 52, -0.1; n=130, 251 | 3 | 13 |
| Left eye, Week 52, 0; n=130, 251 | 121 | 218 |
| Left eye, Week 52, 0.1; n=130, 251 | 3 | 12 |
| Left eye, Week 52, 0.2; n=130, 251 | 0 | 0 |
| Left eye, Week 52, 0.3; n=130, 251 | 1 | 2 |
| Left eye, Week 52, 0.4; n=130, 251 | 0 | 0 |
| Left eye, Week 52, 0.5; n=130, 251 | 0 | 0 |
| Left eye, Week 52, 0.6; n=130, 251 | 0 | 1 |
| Left eye, Week 52, 0.7; n=130, 251 | 0 | 0 |
| Left eye, Week 52, 0.8; n=130, 251 | 0 | 0 |
| Left eye, Week 52, >=0.9; n=130, 251 | 0 | 0 |
| Left eye, Week 52, >=0.3; n=130, 251 | 1 | 3 |
| Left eye, Week 52, >=0.5; n=130, 251 | 0 | 1 |
| Left eye, Week 52, >=1.0; n=130, 251 | 0 | 0 |
| Right eye, Week 52, <-0.3; n=130, 251 | 0 | 0 |
| Right eye, Week 52, -0.3; n=130, 251 | 1 | 0 |
| Right eye, Week 52, -0.2; n=130, 251 | 1 | 5 |
| Right eye, Week 52, -0.1; n=130, 251 | 0 | 10 |
| Right eye, Week 52, 0; n=130, 251 | 122 | 218 |
| Right eye, Week 52, 0.1; n=130, 251 | 4 | 13 |
| Right eye, Week 52, 0.2; n=130, 251 | 0 | 2 |
| Right eye, Week 52, 0.3; n=130, 251 | 1 | 1 |
| Right eye, Week 52, 0.4; n=130, 251 | 1 | 2 |
| Right eye, Week 52, 0.5; n=130, 251 | 0 | 0 |
| Right eye, Week 52, 0.6; n=130, 251 | 0 | 0 |
| Right eye, Week 52, 0.7; n=130, 251 | 0 | 0 |
| Right eye, Week 52, 0.8; n=130, 251 | 0 | 0 |
| Right eye, Week 52, >=0.9; n=130, 251 | 0 | 0 |
| Right eye, Week 52, >=0.3; n=130, 251 | 2 | 3 |
| Right eye, Week 52, >=0.5; n=130, 251 | 0 | 0 |
| Right eye, Week 52, >=1.0; n=130, 251 | 0 | 0 |
| Left eye, Week 104, <-0.3; n=104, 198 | 0 | 0 |
| Left eye, Week 104, -0.3; n=104, 198 | 0 | 0 |
| Left eye, Week 104, -0.2; n=104, 198 | 2 | 5 |
| Left eye, Week 104, -0.1; n=104, 198 | 3 | 11 |
| Left eye, Week 104, 0; n=104, 198 | 94 | 175 |
| Left eye, Week 104, 0.1; n=104, 198 | 5 | 5 |
| Left eye, Week 104, 0.2; n=104, 198 | 0 | 0 |
| Left eye, Week 104, 0.3; n=104, 198 | 0 | 0 |
| Left eye, Week 104, 0.4; n=104, 198 | 0 | 0 |
| Left eye, Week 104, 0.5; n=104, 198 | 0 | 0 |
| Left eye, Week 104, 0.6; n=104, 198 | 0 | 1 |
| Left eye, Week 104, 0.7; n=104, 198 | 0 | 0 |
| Left eye, Week 104, 0.8; n=104, 198 | 0 | 1 |
| Left eye, Week 104, >=0.9; n=104, 198 | 0 | 0 |
| Left eye, Week 104, >=0.3; n=104, 198 | 0 | 2 |
| Left eye, Week 104, >=0.5; n=104, 198 | 0 | 2 |
| Left eye, Week 104, >=1.0; n=104, 198 | 0 | 0 |
| Right eye, Week 104, <-0.3; n=104, 198 | 0 | 0 |
| Right eye, Week 104, -0.3; n=104, 198 | 1 | 0 |
| Right eye, Week 104, -0.2; n=104, 198 | 1 | 5 |
| Right eye, Week 104, -0.1; n=104, 198 | 2 | 14 |
| Right eye, Week 104, 0; n=104, 198 | 97 | 174 |
| Right eye, Week 104, 0.1; n=104, 198 | 3 | 2 |
| Right eye, Week 104, 0.2; n=104, 198 | 0 | 2 |
| Right eye, Week 104, 0.3; n=104, 198 | 0 | 0 |
| Right eye, Week 104, 0.4; n=104, 198 | 0 | 0 |
| Right eye, Week 104, 0.5; n=104, 198 | 0 | 0 |
| Right eye, Week 104, 0.6; n=104, 198 | 0 | 0 |
| Right eye, Week 104, 0.7; n=104, 198 | 0 | 1 |
| Right eye, Week 104, 0.8; n=104, 198 | 0 | 0 |
| Right eye, Week 104, >=0.9; n=104, 198 | 0 | 0 |
| Right eye, Week 104, >=0.3; n=104, 198 | 0 | 1 |
| Right eye, Week 104, >=0.5; n=104, 198 | 0 | 1 |
| Right eye, Week 104, >=1.0; n=104, 198 | 0 | 0 |
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.
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | 0.01 ± 0.210 | 0.00 ± 0.113 |
| Left eye, Week 104; n=104, 198 | 0.02 ± 0.210 | 0.01 ± 0.186 |
| Right eye, Week 52; n=130, 251 | -0.01 ± 0.229 | 0.00 ± 0.154 |
| Right eye, Week 104; n=104, 198 | 0.02 ± 0.187 | 0.01 ± 0.186 |
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.
| participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52, >=0.3; n=130, 251 | 4 | 4 |
| Left eye, Week 52, >=0.5; n=130, 251 | 1 | 0 |
| Left eye, Week 52, >=1.0; n=130, 251 | 1 | 0 |
| Right eye, Week 52, >=0.3; n=130, 251 | 3 | 8 |
| Right eye, Week 52, >=0.5; n=130, 251 | 1 | 2 |
| Right eye, Week 52, >=1.0; n=130, 251 | 1 | 0 |
| Left eye, Week 104, >=0.3; n=104, 198 | 6 | 10 |
| Left eye, Week 104, >=0.5; n=104, 198 | 3 | 4 |
| Left eye, Week 104, >=1.0; n=104, 198 | 1 | 1 |
| Right eye, Week 104, >=0.3; n=104, 198 | 3 | 10 |
| Right eye, Week 104, >=0.5; n=104, 198 | 2 | 4 |
| Right eye, Week 104, >=1.0; n=104, 198 | 1 | 2 |
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.
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | 0.12 ± 0.498 | 0.06 ± 0.495 |
| Left eye, Week 104; n=104, 198 | 0.21 ± 0.538 | 0.10 ± 0.506 |
| Right eye, Week 52; n=130, 251 | 0.12 ± 0.511 | 0.06 ± 0.492 |
| Right eye, Week 104; n=104, 198 | 0.21 ± 0.550 | 0.09 ± 0.531 |
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.
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | 0.14 ± 0.432 | 0.09 ± 0.402 |
| Left eye, Week 104; n=104, 198 | 0.21 ± 0.454 | 0.13 ± 0.465 |
| Right eye, Week 52; n=130, 251 | 0.16 ± 0.422 | 0.09 ± 0.410 |
| Right eye, Week 104; n=104, 198 | 0.22 ± 0.452 | 0.13 ± 0.469 |
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.
| mm Hg | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | -0.5 ± 2.04 | -0.3 ± 2.26 |
| Left eye, Week 104; n=104, 198 | -0.8 ± 1.98 | -0.6 ± 2.41 |
| Right eye, Week 52; n=130, 251 | -0.7 ± 2.08 | -0.4 ± 2.33 |
| Right eye, Week 104; n=104, 198 | -1.0 ± 2.17 | -0.7 ± 2.55 |
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.
| participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, IOP = <-10 to -9 | 1 | 0 |
| Left eye, IOP = -8 | 0 | 0 |
| Left eye, IOP = -7 | 0 | 2 |
| Left eye, IOP = -6 | 0 | 0 |
| Left eye, IOP = -5 | 3 | 3 |
| Left eye, IOP = -4 | 5 | 12 |
| Left eye, IOP = -3 | 9 | 19 |
| Left eye, IOP = -2 | 18 | 40 |
| Left eye, IOP = -1 | 22 | 40 |
| Left eye, IOP = 0 | 36 | 50 |
| Left eye, IOP = 1 | 20 | 30 |
| Left eye, IOP = 2 | 7 | 24 |
| Left eye, IOP = 3 | 5 | 19 |
| Left eye, IOP = 4 | 4 | 7 |
| Left eye, IOP = 5 | 0 | 3 |
| Left eye, IOP = 6 | 0 | 2 |
| Left eye, IOP = 7 | 0 | 0 |
| Left eye, IOP = 8 | 0 | 0 |
| Left eye, IOP = 9 | 0 | 0 |
| Left eye, IOP >= 7 | 0 | 0 |
| Left eye, IOP >= 10 | 0 | 0 |
| Left eye, IOP >= 15 | 0 | 0 |
| Right eye, IOP = <-10 to -9 | 0 | 0 |
| Right eye, IOP = -8 | 0 | 1 |
| Right eye, IOP = -7 | 2 | 0 |
| Right eye, IOP = -6 | 0 | 1 |
| Right eye, IOP = -5 | 2 | 4 |
| Right eye, IOP = -4 | 7 | 14 |
| Right eye, IOP = -3 | 9 | 23 |
| Right eye, IOP = -2 | 25 | 43 |
| Right eye, IOP = -1 | 22 | 34 |
| Right eye, IOP = 0 | 28 | 46 |
| Right eye, IOP = 1 | 16 | 31 |
| Right eye, IOP = 2 | 13 | 27 |
| Right eye, IOP = 3 | 3 | 14 |
| Right eye, IOP = 4 | 2 | 8 |
| Right eye, IOP = 5 | 1 | 2 |
| Right eye, IOP = 6 | 0 | 3 |
| Right eye, IOP = 7 | 0 | 0 |
| Right eye, IOP = 8 | 0 | 0 |
| Right eye, IOP = 9 | 0 | 0 |
| Right eye, IOP >= 7 | 0 | 0 |
| Right eye, IOP >= 10 | 0 | 0 |
| Right eye, IOP >= 15 | 0 | 0 |
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 in IOP was calculated by subtracting the baseline value from the Week 104 value.
| participants | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, IOP = <-10 to -9 | 0 | 0 |
| Left eye, IOP = -8 | 0 | 1 |
| Left eye, IOP = -7 | 0 | 0 |
| Left eye, IOP = -6 | 2 | 3 |
| Left eye, IOP = -5 | 0 | 7 |
| Left eye, IOP = -4 | 6 | 10 |
| Left eye, IOP = -3 | 15 | 19 |
| Left eye, IOP = -2 | 17 | 31 |
| Left eye, IOP = -1 | 15 | 32 |
| Left eye, IOP = 0 | 21 | 32 |
| Left eye, IOP = 1 | 19 | 30 |
| Left eye, IOP = 2 | 5 | 16 |
| Left eye, IOP = 3 | 3 | 7 |
| Left eye, IOP = 4 | 0 | 6 |
| Left eye, IOP = 5 | 1 | 2 |
| Left eye, IOP = 6 | 0 | 1 |
| Left eye, IOP = 7 | 0 | 1 |
| Left eye, IOP = 8 | 0 | 0 |
| Left eye, IOP = 9 | 0 | 0 |
| Left eye, IOP >= 7 | 0 | 1 |
| Left eye, IOP >= 10 | 0 | 0 |
| Left eye, IOP >= 15 | 0 | 0 |
| Right eye, IOP = <-10 to -9 | 0 | 0 |
| Right eye, IOP = -8 | 0 | 1 |
| Right eye, IOP = -7 | 0 | 2 |
| Right eye, IOP = -6 | 2 | 1 |
| Right eye, IOP = -5 | 5 | 7 |
| Right eye, IOP = -4 | 4 | 15 |
| Right eye, IOP = -3 | 10 | 17 |
| Right eye, IOP = -2 | 24 | 32 |
| Right eye, IOP = -1 | 21 | 22 |
| Right eye, IOP = 0 | 12 | 46 |
| Right eye, IOP = 1 | 16 | 23 |
| Right eye, IOP = 2 | 6 | 13 |
| Right eye, IOP = 3 | 1 | 8 |
| Right eye, IOP = 4 | 1 | 5 |
| Right eye, IOP = 5 | 1 | 2 |
| Right eye, IOP = 6 | 1 | 2 |
| Right eye, IOP = 7 | 0 | 2 |
| Right eye, IOP = 8 | 0 | 0 |
| Right eye, IOP = 9 | 0 | 0 |
| Right eye, IOP >= 7 | 0 | 2 |
| Right eye, IOP >= 10 | 0 | 0 |
| Right eye, IOP >= 15 | 0 | 0 |
ETDRS charts are used to measure VA (the ability to resolve fine image details). Participants must have had a best-corrected distance VA of =\< 0.18 on the LogMAR scale using ETDRS charts in both eyes measured separately. The LogMAR scale (expressed as the \[decadic\] logarithm of the minimum angle of resolution \[range from +1.00 to -0.30\]) converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA.
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye, Week 52; n=130, 251 | -0.027 ± 0.0729 | -0.013 ± 0.0778 |
| Left eye, Week 104; n=104, 198 | -0.035 ± 0.0740 | -0.023 ± 0.0858 |
| Right eye, Week 52; n=130, 251 | -0.023 ± 0.0810 | -0.014 ± 0.0852 |
| Right eye, Week 104; n=104, 198 | -0.025 ± 0.0992 | -0.024 ± 0.0899 |
The funduscopic horizontal cup-to-risk ratio assesses the progression of glaucoma. Percent change from baseline in funduscopic horizontal cup-to-disc ratio at Week 104 was calculated by substracting the baseline value from the Week 104 value (both expressed as a percent). The cup-to-disc ratio compares the diameter of the "cup" portion of the optic disc with the total diameter of the optic disc. A large cup-to-disc ratio may imply glaucoma or other pathology.
| percent change | Placebo | FF 110 mcg QD |
|---|---|---|
| Left eye | 0.0 ± 7.23 | 0.7 ± 7.58 |
| Right eye | 0.0 ± 7.31 | 0.0 ± 7.39 |
rTNSS was evaluated on a 4-point categorical scale (sum of the scores for rhinorrhea, nasal congestion, nasal itching, and sneezing; range=0-12). The data collected were used as a measure for treatment compliance. The scores on the scale were based on the severity of each nasal symptom: 0=none (symptom is not present); 1=mild (sign/symptom is clearly present but minimal awareness; easily tolerated); 2=moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3=severe (sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping).
| scores on a scale | Placebo | FF 110 mcg QD |
|---|---|---|
| Week 1 to 26 | -2.12 ± 0.17 | -3.19 ± 0.12 |
| Week 27 to 52 | -2.52 ± 0.21 | -3.86 ± 0.15 |
| Week 53 to 78 | -2.56 ± 0.23 | -3.89 ± 0.16 |
| Week 79 to 104 | -2.59 ± 0.25 | -4.10 ± 0.18 |
| Week 1 to 104 | -2.30 ± 0.18 | -3.45 ± 0.13 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 7/181 (3.9%) | 97/181 (53.6%) |
| FF 110 mcg QD | — | 12/367 (3.3%) | 232/367 (63.2%) |
| Event | Placebo | FF 110 mcg QD |
|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/181 | 0/367 |
| Intra-uterine deathPregnancy, puerperium and perinatal conditions | 1/181 | 0/367 |
| Upper airway obstructionRespiratory, thoracic and mediastinal disorders | 1/181 | 0/367 |
| CholelithiasisHepatobiliary disorders | 1/181 | 0/367 |
| Suicide attemptPsychiatric disorders | 1/181 | 0/367 |
| NephrolithiasisRenal and urinary disorders | 1/181 | 0/367 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/181 | 2/367 |
| ContusionInjury, poisoning and procedural complications | 0/181 | 1/367 |
| Rib fractureInjury, poisoning and procedural complications | 0/181 | 1/367 |
| Tibia fractureInjury, poisoning and procedural complications | 0/181 | 1/367 |
| Event | Placebo | FF 110 mcg QD |
|---|---|---|
| EpistaxisRespiratory, thoracic and mediastinal disorders | 34/181 | 123/367 |
| SinusitisInfections and infestations | 31/181 | 47/367 |
| Upper respiratory tract infectionInfections and infestations | 29/181 | 52/367 |
| NasopharyngitisInfections and infestations | 17/181 | 44/367 |
| InfluenzaInfections and infestations | 16/181 | 25/367 |
| BronchitisInfections and infestations | 8/181 | 31/367 |
| Nasal ulcerRespiratory, thoracic and mediastinal disorders | 3/181 | 30/367 |
| HeadacheNervous system disorders | 13/181 | 29/367 |
| Viral upper respiratory tract infectionInfections and infestations | 12/181 | 27/367 |
| Nasal septum ulcerationRespiratory, thoracic and mediastinal disorders | 6/181 | 24/367 |
| Age, Continuous(Years) | Placebo | FF 110 mcg QD | Total |
|---|---|---|---|
| Mean | 38.0 ± 13.34 | 37.0 ± 13.48 | 37.4 ± 13.43 |
| Gender(Participants) | Placebo | FF 110 mcg QD | Total |
|---|---|---|---|
| Female | 116 | 255 | 371 |
| Male | 65 | 112 | 177 |
| Race/Ethnicity, Customized(participants) | Placebo | FF 110 mcg QD | Total |
|---|---|---|---|
| African American/African Heritage | 29 | 50 | 79 |
| American Indian or Alaska Native | 1 | 4 | 5 |
| Central/South Asian Heritage | 0 | 1 | 1 |
| Japanese/East Asian/South East Asian Heritage | 2 | 6 | 8 |
| Mixed Asian Heritage | 0 | 1 | 1 |
| Native Hawaiian or other Pacific Islander | 2 | 2 | 4 |
| White | 146 | 303 | 449 |
| African American/African Heritage & White | 1 | 0 | 1 |
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