Rhinitis, Allergic, Perennial
Conditions
Keywords
fluticasone propionate, seasonal allergic rhinitis, fluticasone furoate, experience, GW685698X, preference
Brief summary
The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105924)
Interventions
DRUGFPNS
fluticasone propionate nasal spray
DRUGFFNS
fluticasone furoate nasal spray
DRUGplacebo FPNS
placebo nasal spray matching fluticasone propionate nasal spray
DRUGplacebo FFNS
placebo nasal spray matching fluticasone furoate nasal spray
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Subject has provided an appropriately signed and dated informed consent. * Otherwise healthy outpatient with fall allergy * Subject is treatable on an outpatient basis. * Age * 18 years or age or older at time of Visit 2 * Male or eligible female * Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant. * 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: * Abstinence * Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days). * Oral contraceptive (either combined estrogen/progestin or progestin only) * Injectable progestogen * Implants of levonorgestrel * Percutaneous contraceptive patches * Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year, * Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject * Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide * Estrogenic vaginal ring * Diagnosis of SAR * SAR is defined as follows: * A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal symptoms) during each of the last two fall allergy seasons, and * A positive skin test (by prick method) to fall allergen prevalent to the geographic area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1. * A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing. * In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR. * Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization. * Adequate exposure to seasonal pollen * Subject resides within a geographical region where exposure to fall seasonal allergen is expected to be significant during the entire study period. * Subject does not plan to travel outside this area for more than 48 hours of the study period. * Ability to comply with study procedures * Subject understands and is willing, able and likely to comply with study procedures and restrictions. * Literate * Subject must be able to read, comprehend, and record information in English
Exclusion criteria
* Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST). * Significant concomitant medical conditions, defined as but not limited to: * A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study. * A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug * Nasal (eg, nasal septum) injury or surgery in the last 3 months * Asthma, with the exception of mild intermittent asthma \[National Asthma Education and Prevention Program (NARPP) Guidelines, 2002\]. * Rhinitis medicamentosa * Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period * Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator * Current or history of glaucoma and/or cataracts or ocular herpes simplex * Physical impairment that would affect subject's ability to participate safely and fully in the study * Clinical evidence of a Candida infection of the nose * History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results * History of adrenal insufficiency * History of shingles * Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease. * Use of other corticosteroids, defined as: * Intranasal corticosteroid within four weeks prior to Visit 1. * Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1. * Use of other allergy medications within the timeframe indicated relative to Visit 1 * Intranasal cromolyn within 14 days prior to Visit 1 * Short-acting prescription and OTC antihistamines, including antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 3 days prior to Visit 1 * Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine * Oral or intranasal decongestants within 3 days prior to Visit 1 * Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1 * Oral antileukotrienes within 3 days prior to Visit 1 * Subcutaneous omalizumab (Xolair) within 5 months of Visit 1 * Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1 * Use of other medications that may affect allergic rhinitis or its symptoms * Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug * Chronic use of long-acting beta-agonists (e.g., salmeterol) * Chronic use of other intranasally administered medications (e.g., calcitonin-salmon) * Nasal irrigation solutions * Use of immunosuppressive medications 8 weeks prior to screening and during the study * Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole * Immunotherapy * Subjects may be enrolled into the study if the immunotherapy was not initiated within 30 days of Visit 1, if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study. * Allergy/Intolerance * Known hypersensitivity to corticosteroids or any excipients in the product * Clinical trial/experimental medication experience * Has recent exposure to an investigational study drug within 30 days of Visit 1 * Participation in a previous or current GSK FFNS study * Positive or inconclusive pregnancy test or female who is breastfeeding * Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2 * Affiliation with investigational site * 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. * Current tobacco use * Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | End of Crossover Period (Day 22) | Participants 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. Participant could also choose I have no preference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods |
| 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) | Participants 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. Participant could also choose I have no preference. |
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 96 |
| Placebo - FF/FP Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group. | 95 |
| 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. | 95 |
| Placebo - FP/FF Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group. | 91 |
| Total | 377 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Pre-treatment | Other | 0 | 1 | 0 | 0 |
| Treatment Period 1 | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Treatment Period 1 | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Treatment Period 1 | Protocol Violation | 0 | 0 | 1 | 0 |
| Treatment Period 2 | Other | 0 | 1 | 0 | 0 |
| Treatment Period 2 | Protocol Violation | 1 | 0 | 0 | 0 |
| Washout | Adverse Event | 2 | 1 | 0 | 0 |
| Washout | Failed to meet continuation criteria | 16 | 5 | 14 | 6 |
| Washout | Other | 1 | 1 | 2 | 3 |
| Washout | Protocol Violation | 1 | 1 | 0 | 0 |
| Washout | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Fluticasone Furoate NS/Fluticasone Propionate NS | Placebo - FF/FP | Fluticasone Propionate NS/Fluticasone Furoate NS | Placebo - FP/FF | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 13.89 | 42 years STANDARD_DEVIATION 12.48 | 40.5 years STANDARD_DEVIATION 12.29 | 39.7 years STANDARD_DEVIATION 14.32 | 39.9 years STANDARD_DEVIATION 13.33 |
| Gender Female | 62 Participants | 73 Participants | 67 Participants | 60 Participants | 262 Participants |
| Gender Male | 34 Participants | 22 Participants | 28 Participants | 31 Participants | 115 Participants |
| Race/Ethnicity, Customized African American/African-American Indian/Alaskan | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized African American/African Heritage & White | 0 participants | 0 participants | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized American/African Heritage | 8 participants | 8 participants | 10 participants | 8 participants | 34 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 3 participants | 1 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 88 participants | 84 participants | 82 participants | 80 participants | 334 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 173 | 8 / 171 | 10 / 176 | 9 / 175 |
| serious Total, serious adverse events | 0 / 173 | 0 / 171 | 0 / 176 | 0 / 175 |
Outcome results
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
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.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Population: Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period One | -2.7 Scores on a scale | Standard Error 0.29 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period Two | -2.5 Scores on a scale | Standard Error 0.29 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period Two | -1.9 Scores on a scale | Standard Error 0.24 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period One | -1.5 Scores on a scale | Standard Error 0.2 |
| Total | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period One | -2.4 Scores on a scale | Standard Error 0.24 |
| Total | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period Two | -2.7 Scores on a scale | Standard Error 0.27 |
| Placebo - FP/FF | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period One | -1.6 Scores on a scale | Standard Error 0.22 |
| Placebo - FP/FF | Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos | Change from Baseline Treatment Period Two | -1.7 Scores on a scale | Standard Error 0.21 |
Comparison: FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.p-value: <0.00195% CI: [-1.5, -0.6]ANCOVA
Comparison: FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.p-value: 0.00495% CI: [-1.1, -0.2]ANCOVA
Primary
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Participants 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. Participant could also choose I have no preference.
Time frame: End of Crossover Period (Day 22)
Population: Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Propionate Nasal Spray | 21 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Furoate Nasal Spray | 43 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | No Preference | 13 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Propionate Nasal Spray | 17 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Furoate Nasal Spray | 41 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | No Preference | 19 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Furoate Nasal Spray | 84 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | No Preference | 32 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor | Preferred - Fluticasone Propionate Nasal Spray | 38 Participants |
Comparison: Statistical analysis applies to FFNS and FPNS categories.p-value: <0.001Cochran-Mantel-Haenszel
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
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.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Population: Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | 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 | Change from Baseline Treatment Period One | -2.8 Scores on a scale | Standard Error 0.3 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | 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 | Change from Baseline Treatment Period Two | -2.6 Scores on a scale | Standard Error 0.31 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | 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 | Change from Baseline Treatment Period Two | -2.0 Scores on a scale | Standard Error 0.26 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | 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 | Change from Baseline Treatment Period One | -1.6 Scores on a scale | Standard Error 0.21 |
| Total | 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 | Change from Baseline Treatment Period One | -2.6 Scores on a scale | Standard Error 0.26 |
| Total | 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 | Change from Baseline Treatment Period Two | -2.8 Scores on a scale | Standard Error 0.28 |
| Placebo - FP/FF | 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 | Change from Baseline Treatment Period One | -1.7 Scores on a scale | Standard Error 0.23 |
| Placebo - FP/FF | 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 | Change from Baseline Treatment Period Two | -1.9 Scores on a scale | Standard Error 0.24 |
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
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.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Population: Intent-to-Treat (ITT) population consisted of all participants who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | 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 | Change From Baseline Treatment Period One | -2.5 Scores on a scale | Standard Error 0.29 |
| Fluticasone Furoate NS/Fluticasone Propionate NS | 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 | Change From Baseline Treatment Period Two | -2.4 Scores on a scale | Standard Error 0.29 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | 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 | Change From Baseline Treatment Period Two | -1.9 Scores on a scale | Standard Error 0.25 |
| Fluticasone Propionate NS/Fluticasone Furoate NS | 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 | Change From Baseline Treatment Period One | -1.3 Scores on a scale | Standard Error 0.21 |
| Total | 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 | Change From Baseline Treatment Period One | -2.4 Scores on a scale | Standard Error 0.26 |
| Total | 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 | Change From Baseline Treatment Period Two | -2.6 Scores on a scale | Standard Error 0.3 |
| Placebo - FP/FF | 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 | Change From Baseline Treatment Period One | -1.6 Scores on a scale | Standard Error 0.23 |
| Placebo - FP/FF | 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 | Change From Baseline Treatment Period Two | -1.6 Scores on a scale | Standard Error 0.22 |
Secondary
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Propionate Nasal Spray | 42 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Furoate Nasal Spray | 19 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | No Preference | 16 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Propionate Nasal Spray | 37 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Furoate Nasal Spray | 28 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | No Preference | 12 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Furoate Nasal Spray | 47 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | No Preference | 28 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use | Preferred - Fluticasone Propionate Nasal Spray | 79 Participants |
Secondary
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
Time frame: End of Crossover Period (Day 22)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Propionate Nasal Spray | 17 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Furoate Nasal Spray | 37 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | No Preference | 23 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Propionate Nasal Spray | 14 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Furoate Nasal Spray | 49 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | No Preference | 14 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Furoate Nasal Spray | 86 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | No Preference | 37 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist | Preferred - Fluticasone Propionate Nasal Spray | 31 Participants |
Secondary
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Participants 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. Participant could also choose I have no preference.
Time frame: End of Crossover Period (Day 22)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Propionate Nasal Spray | 15 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Furoate Nasal Spray | 43 Participants |
| Fluticasone Furoate NS/Fluticasone Propionate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | No Preference | 19 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Propionate Nasal Spray | 17 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Furoate Nasal Spray | 46 Participants |
| Fluticasone Propionate NS/Fluticasone Furoate NS | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | No Preference | 14 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Furoate Nasal Spray | 89 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | No Preference | 33 Participants |
| Total | Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat | Preferred - Fluticasone Propionate Nasal Spray | 32 Participants |