| Primary | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos | Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used. | Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data. | Posted | | Mean | Standard Error | Scores on a scale | | Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Placebo FF/FP | Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. | | OG002 | Fluticasone Propionate NS/Fluticasone Furoate NS | Subjects 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. | | OG003 | Placebo FP/FF | Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group. |
| | Units | Counts |
|---|
| Participants | - OG00090
- OG00186
- OG00290
- OG003
|
| | Title | Denominators | Categories |
|---|
| Change from Baseline Treatment Period 1 | | | Title | Measurements |
|---|
| - OG000-2.7± 0.26
- OG001-1.7± 0.22
- OG002-2.2± 0.23
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| FFNS combined across treatment arms 1 (FFNS/FPNS) & 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) & 2 (Placebo FF/FP). | ANCOVA | | <0.001 | | Mean Difference (Net) | -0.8 | Standard Error of the Mean | 0.24 | | 95 | -1.3 | -0.3 | | | Mean Difference = Mean Change in FFNS - Mean Change in Placebo. | No | Superiority or Other | | | |
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| Primary | Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Subjects assessed preference of scent/odor 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. Subject could also choose "I have no preference." | 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. | Posted | | Number | | Participants | | End of Crossover Period (Day 22) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Fluticasone Propionate NS/Fluticasone Furoate NS | Subjects 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. |
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| Secondary | Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos | Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe. | Intent-to-Treat(ITT) population. A subject in the FP/FF group had no baseline daytime TNSS; however, does have a baseline nighttime TNSS, that value serves as the baseline 24-hour TNSS. Therefore there are 90 24-hour & nighttime TNSS observations available in the FP/FF group, but only 89 daytime TNSS observations. | Posted | | Mean | Standard Error | Scores on a scale | | Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Placebo FF/FP | Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. | | OG002 | Fluticasone Propionate NS/Fluticasone Furoate NS |
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| Secondary | Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos | Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. | Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data. | Posted | | Mean | Standard Error | Scores on a scale | | Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Placebo FF/FP | Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. | | OG002 | Fluticasone Propionate NS/Fluticasone Furoate NS | |
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| Secondary | Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat | Subjects assessed preference over leaking out of nose/down throat 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. Subject could also choose "I have no preference." | 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. | Posted | | Number | | Participants | | End of Crossover Period (Day 22) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Fluticasone Propionate NS/Fluticasone Furoate NS | Subjects 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. |
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| Secondary | Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use | Subjects 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. Subject could also choose "I have no preference." | 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. | Posted | | Number | | Participants | | End of Crossover Period (Day 22) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Fluticasone Propionate NS/Fluticasone Furoate NS | Subjects 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. |
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| Secondary | Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist | Subjects assessed preference over gentleness of mist 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. Subject could also choose "I have no preference." | 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. | Posted | | Number | | Participants | | End of Crossover Period (Day 22) | | | | ID | Title | Description |
|---|
| OG000 | Fluticasone Furoate NS/Fluticasone Propionate NS | Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg 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. | | OG001 | Fluticasone Propionate NS/Fluticasone Furoate NS | Subjects 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. |
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