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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double-Blind, Crossover Assignment |
| Condition: |
Seasonal Allergic Rhinitis |
| Interventions: |
Drug: fluticasone propionate Drug: fluticasone furoate Drug: placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
| Description | |
|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD. |
| Placebo - FF/FP | Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD. |
| Placebo - FP/FF | Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group. |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | |
|---|---|---|---|---|
| STARTED | 96 | 95 | 95 | 91 |
| COMPLETED | 96 | 94 | 95 | 91 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
| Unknown | 0 | 1 | 0 | 0 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | |
|---|---|---|---|---|
| STARTED | 96 | 94 | 95 | 91 |
| COMPLETED | 96 | 94 | 93 | 90 |
| NOT COMPLETED | 0 | 0 | 2 | 1 |
| Lost to Follow-up | 0 | 0 | 1 | 0 |
| Protocol Violation | 0 | 0 | 1 | 0 |
| Lack of Efficacy | 0 | 0 | 0 | 1 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | |
|---|---|---|---|---|
| STARTED | 96 | 94 | 93 | 90 |
| COMPLETED | 76 | 84 | 77 | 81 |
| NOT COMPLETED | 20 | 10 | 16 | 9 |
| Adverse Event | 2 | 1 | 0 | 0 |
| Protocol Violation | 1 | 1 | 0 | 0 |
| Withdrawal by Subject | 0 | 2 | 0 | 0 |
| Failed to meet continuation criteria | 16 | 5 | 14 | 6 |
| Unknown | 1 | 1 | 2 | 3 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | |
|---|---|---|---|---|
| STARTED | 76 | 84 | 77 | 81 |
| COMPLETED | 75 | 83 | 77 | 81 |
| NOT COMPLETED | 1 | 1 | 0 | 0 |
| Protocol Violation | 1 | 0 | 0 | 0 |
| Unknown | 0 | 1 | 0 | 0 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | |
|---|---|---|---|---|
| STARTED | 75 | 83 | 77 | 81 |
| COMPLETED | 75 | 83 | 77 | 81 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD. |
| Placebo - FF/FP | Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD. |
| Placebo - FP/FF | Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group. |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | Total | |
|---|---|---|---|---|---|
|
Number of Participants [units: participants] |
96 | 95 | 95 | 91 | 377 |
|
Age [units: years] Mean ± Standard Deviation |
37.3 ± 13.89 | 42 ± 12.48 | 40.5 ± 12.29 | 39.7 ± 14.32 | 39.9 ± 13.33 |
|
Gender [units: participants] |
|||||
| Female | 62 | 73 | 67 | 60 | 262 |
| Male | 34 | 22 | 28 | 31 | 115 |
|
Race/Ethnicity, Customized [units: participants] |
|||||
| American/African Heritage | 8 | 8 | 10 | 8 | 34 |
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 1 | 1 | 5 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| White | 88 | 84 | 82 | 80 | 334 |
| African American/African-American Indian/Alaskan | 0 | 0 | 0 | 1 | 1 |
| African American/African Heritage & White | 0 | 0 | 1 | 1 | 2 |
Outcome Measures
| 1. Primary: | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ] |
| 2. Primary: | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor [ End of Crossover Period (Day 22) ] |
| 3. Secondary: | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat [ End of Crossover Period (Day 22) ] |
| 4. Secondary: | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use [ End of Crossover Period (Day 22) ] |
| 5. Secondary: | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist [ End of Crossover Period (Day 22) ] |
| 6. Secondary: | Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ] |
| 7. Secondary: | Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos [ Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) ] |
Serious Adverse Events
Other Adverse Events
| Time Frame | No text entered. |
|---|---|
| Additional Description | No text entered. |
| Threshold above which other adverse events are reported | 5% |
|---|
| Description | |
|---|---|
| Fluticasone Furoate Nasal Spray | Subjects who received Fluticasone Furoate. |
| Fluticason Propionate Nasal Spray | Subjects who receive Fluticasone Propionate Nasal Spray. |
| Placebo - FF | Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray. |
| Placebo - FP | Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray. |
| Fluticasone Furoate Nasal Spray | Fluticason Propionate Nasal Spray | Placebo - FF | Placebo - FP | |
|---|---|---|---|---|
| Total, other (not including serious) adverse events | ||||
| # participants affected / at risk | 5 | 8 | 10 | 9 |
| Nervous system disorders | ||||
| Headache † A # participants affected / at risk |
5/173 (2.89%) |
8/171 (4.68%) |
10/176 (5.68%) |
9/175 (5.14%) |
| † | Indicates events were collected by systematic assessment. |
|---|---|
| A | Term from vocabulary, MedDRA |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFU105924 |
| Study First Received: | October 2, 2007 |
| Results First Received: | November 14, 2008 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00539006 History of Changes |
| Health Authority: | United States: Food and Drug Administration |