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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] |
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| Female | 62 | 73 | 67 | 60 | 262 |
| Male | 34 | 22 | 28 | 31 | 115 |
|
Race/Ethnicity, Customized [units: participants] |
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| 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) ] |
Hide Outcome Measure 4| Measure Type | Secondary |
|---|---|
| Measure Title | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use |
| Measure Description | Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference." |
| Time Frame | End of Crossover Period (Day 22) |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Intent-to-Treat (ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions. |
| 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. |
| 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. |
| Total | All participants on both arms preference. |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Fluticasone Propionate NS/Fluticasone Furoate NS | Total | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
77 | 77 | 154 |
|
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
[units: Participants] |
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| Preferred - Fluticasone Furoate Nasal Spray | 19 | 28 | 47 |
| Preferred - Fluticasone Propionate Nasal Spray | 42 | 37 | 79 |
| No Preference | 16 | 12 | 28 |
| 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) ] |
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 |