Rhinitis, Allergic, Perennial and Seasonal
Conditions
Keywords
cetirizine, seasonal allergic rhinitis, Quality of Life, fluticasone propionate nasal spray
Brief summary
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.
Interventions
DRUGFPNS
Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray.
DRUGFPNS Placebo
Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays.
DRUGCetirizine
Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle).
Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent: Subject must give their signed and dated written informed consent to participate. Subject must understand and be willing, able, and likely to comply with study procedures and restrictions. Subject must be able to read, comprehend, and record information in English. * Subject is treatable on an outpatient basis. * Age: \>=18 years of age at Visit 1. * Gender: Male or eligible female subjects. A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. OR Childbearing potential with a negative pregnancy test at screening and agreeable to using one of the acceptable contraceptive methods consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study). An eligible female is also not lactating nor planning on becoming pregnant during the study. * Diagnosis of SAR, defined as documented clinical history or physician verification of subject reported historical SAR during each of the last two fall allergy seasons and a positive skin prick test (wheal \>=3 millimeter \[mm\] larger than the negative control) to a prevalent local fall allergen within 12 months prior to Visit 1 or at Visit 1. * Adequate exposure to local fall pollen: Subject resides within a geographical region where exposure to the local fall pollen to which they are sensitized is expected to be moderate or greater during the study period. Subject does not plan to travel outside the geographical region where exposure to local fall pollen to which they are sensitized is expected to be moderate or greater for more than 48 hours during the study period. At Visit 2, the subject must meet the following criteria * Eligible subjects will need to have moderate to severe SAR symptoms, defined as a morning rTNSS of \>=7 on at least four of the last seven days leading up to randomization. This includes the AM assessment on the morning of the randomization visit at Visit 2. * Subjects should demonstrate at least a 70% compliance rate with both their placebo run-in study medications and their e-diary completion prior to randomization. This period includes the day of Visit 1 until the day before randomization at Visit 2. * Subjects should have no significant change in medical condition(s) that would have been exclusionary at Visit 1. * Subjects should not have used any prohibited medications that are detailed in the inclusion/
Exclusion criteria
(including prohibited allergy medications). * Subjects should not have travelled outside the local pollen region for more than 48 hours during the run-in period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal. | Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal | The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value. |
| Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that instant. The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. |
| Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value. |
| Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that instant. The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value. |
| Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days. |
| Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period | Baseline through the entire treatment period (2 weeks) | The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value. |
Countries
United States
Participant flow
Recruitment details
In anticipation of a 5% to 8% dropout rate, this study planned enrolment of 156 participants per treatment group in order to target 144 participants per treatment group, who would provide a full 2 weeks' worth of data.
Pre-assignment details
A total of 978 participants were screened for this study. Of these, 73 were pre-screen failures and 223 were screening/run-in failures. A total of 682 participants were randomized (1:1:1:1 ratio) to receive study treatment.
Participants by arm
| Arm | Count |
|---|---|
| FPNS 200 μg Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks. | 170 |
| Cetirizine 10 mg Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks. | 170 |
| FPNS Matching Placebo Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks. | 171 |
| Cetirizine Matching Placebo Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks. | 171 |
| Total | 682 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | FPNS 200 μg | Cetirizine 10 mg | FPNS Matching Placebo | Cetirizine Matching Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.1 Years STANDARD_DEVIATION 10.66 | 39.2 Years STANDARD_DEVIATION 11.41 | 41.3 Years STANDARD_DEVIATION 11.29 | 40.4 Years STANDARD_DEVIATION 11.84 | 40.3 Years STANDARD_DEVIATION 11.31 |
| Race/Ethnicity, Customized African American/African Heritage | 34 Participants | 20 Participants | 31 Participants | 35 Participants | 120 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 2 Participants | 2 Participants | 5 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Mixed Race | 0 Participants | 6 Participants | 3 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Not Captured by Study Site | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 129 Participants | 142 Participants | 128 Participants | 127 Participants | 526 Participants |
| Sex: Female, Male Female | 96 Participants | 113 Participants | 110 Participants | 109 Participants | 428 Participants |
| Sex: Female, Male Male | 74 Participants | 57 Participants | 61 Participants | 62 Participants | 254 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 | 10 / 170 | 13 / 170 | 10 / 171 | 10 / 171 |
| serious Total, serious adverse events | 0 / 170 | 0 / 170 | 0 / 171 | 0 / 171 |
Outcome results
Primary
Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period
The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period | -2.2 Scores on a scale | Standard Error 0.19 |
| Cetirizine 10 mg | Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period | -1.9 Scores on a scale | Standard Error 0.18 |
| FPNS Matching Placebo | Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period | -1.5 Scores on a scale | Standard Error 0.18 |
| Cetirizine Matching Placebo | Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period | -0.9 Scores on a scale | Standard Error 0.16 |
p-value: 0.27895% CI: [-0.7, 0.2]ANCOVA
Secondary
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period
The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that instant. The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period | -1.9 Scores on a scale | Standard Error 0.18 |
| Cetirizine 10 mg | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period | -1.3 Scores on a scale | Standard Error 0.17 |
| FPNS Matching Placebo | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period | -1.2 Scores on a scale | Standard Error 0.18 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period | -0.6 Scores on a scale | Standard Error 0.15 |
Secondary
Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period
The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that instant. The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: Ocular Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period | -1.3 Scores on a scale | Standard Error 0.15 |
| Cetirizine 10 mg | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period | -1.1 Scores on a scale | Standard Error 0.14 |
| FPNS Matching Placebo | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period | -1.1 Scores on a scale | Standard Error 0.16 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period | -0.5 Scores on a scale | Standard Error 0.13 |
Secondary
Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period | -1.6 Scores on a scale | Standard Error 0.16 |
| Cetirizine 10 mg | Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period | -1.4 Scores on a scale | Standard Error 0.16 |
| FPNS Matching Placebo | Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period | -1.2 Scores on a scale | Standard Error 0.16 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period | -0.8 Scores on a scale | Standard Error 0.14 |
Secondary
Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period
The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period | -3.9 Scores on a scale | Standard Error 0.34 |
| Cetirizine 10 mg | Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period | -3.4 Scores on a scale | Standard Error 0.34 |
| FPNS Matching Placebo | Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period | -2.7 Scores on a scale | Standard Error 0.34 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period | -1.7 Scores on a scale | Standard Error 0.3 |
Secondary
Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period
Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.
Time frame: Baseline through the entire treatment period (2 weeks)
Population: ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Sneezing | -0.6 Scores on a scale | Standard Error 0.05 |
| FPNS 200 μg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal itching | -0.6 Scores on a scale | Standard Error 0.05 |
| FPNS 200 μg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal congestion | -0.5 Scores on a scale | Standard Error 0.05 |
| FPNS 200 μg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Runny nose | -0.5 Scores on a scale | Standard Error 0.05 |
| Cetirizine 10 mg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal itching | -0.5 Scores on a scale | Standard Error 0.05 |
| Cetirizine 10 mg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Runny nose | -0.4 Scores on a scale | Standard Error 0.05 |
| Cetirizine 10 mg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal congestion | -0.4 Scores on a scale | Standard Error 0.04 |
| Cetirizine 10 mg | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Sneezing | -0.6 Scores on a scale | Standard Error 0.05 |
| FPNS Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal congestion | -0.3 Scores on a scale | Standard Error 0.05 |
| FPNS Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal itching | -0.4 Scores on a scale | Standard Error 0.05 |
| FPNS Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Runny nose | -0.4 Scores on a scale | Standard Error 0.05 |
| FPNS Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Sneezing | -0.4 Scores on a scale | Standard Error 0.05 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal itching | -0.2 Scores on a scale | Standard Error 0.04 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Nasal congestion | -0.2 Scores on a scale | Standard Error 0.04 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Sneezing | -0.2 Scores on a scale | Standard Error 0.05 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period | Runny nose | -0.3 Scores on a scale | Standard Error 0.05 |
Secondary
Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.
The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.
Time frame: Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FPNS 200 μg | Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal. | -1.0 Scores on a scale | Standard Error 0.1 |
| Cetirizine 10 mg | Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal. | -0.6 Scores on a scale | Standard Error 0.09 |
| FPNS Matching Placebo | Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal. | -0.8 Scores on a scale | Standard Error 0.1 |
| Cetirizine Matching Placebo | Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal. | -0.5 Scores on a scale | Standard Error 0.08 |