Rhinitis, Seasonal Rhinitis
Conditions
Keywords
Seasonal allergies
Brief summary
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
Interventions
10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days
DRUGPlacebo
Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days
DRUGLoratadine
10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female participants of reproductive potential must have a negative pregnancy test and agree to use acceptable methods of birth control throughout the study. * Participant is willing to stop use of current decongestant and allergy medications during the trial. * Participant has a documented or self-reported history of seasonal allergy. * Participant has documented positive skin testing to spring pollen allergens. * Participant has nasal congestion of at least moderate severity. * Participant has mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤138/88 mmHg. * Participant has clinically acceptable physical exam and 12-lead electrocardiogram (ECG). * Participant is without clinically significant disease. * Participant must agree not to take monoamine oxidase inhibitor (MAOI) from 14 days before trial participation until 14 days after the end of the trial. * Participant must sign an informed consent form
Exclusion criteria
* Participants must not have any significant medical condition that is a contraindication to the use of phenylephrine HCl or loratadine, such as thyroid disease, uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, or prostatic hypertrophy. * Participants with a history or presence of hypertension. * Participants who have started allergen immunotherapy within a month preceding enrollment or starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation. * Participants who have a known allergy or intolerance to phenylephrine HCl, any other decongestant, loratadine, desloratadine, or any other antihistamine. * Participants with persistent asthma, rhinitis medicamentosa, or acute or chronic sinusitis, or a history of significant sinusitis within one month of enrollment. * Participant with a history of intermittent asthma may be considered for enrollment provided they have no asthma symptoms at the time of enrollment and use only a short acting beta2-agonist less than twice weekly. * Participants who have used systemic (oral, rectal, injectable), topical, or nasal corticosteroids in the last 30 days (up to 1% topical hydrocortisone is permitted). * Participants using a leukotriene receptor antagonist for maintenance treatment of asthma. * Participant with a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. * Participant with a history of immunological disease or malignancy within the past 5 years, with the exception of non-melanoma skin cancer. * Participant with positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator). * Participant has had major surgery or participated in another investigational study within 4 weeks prior to the Screening Visit. * Participants taking any herbal supplements during trial conduct.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | Baseline, Day 7 | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
| Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline and Day 2, 3, 4, 5, 6, and 7 | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
| Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. |
| Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline and Days 2, 3, 4, 5, 6, and 7 | The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
| Time to Maximal Effect | Baseline up to Day 7 | Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest. |
| Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | Baseline, Day 7 | The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
| Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PE 10 mg PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment. | 109 |
| PE 20 mg PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment. | 108 |
| PE 30 mg PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment. | 107 |
| PE 40 mg PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment. | 112 |
| Placebo Matching placebo was administered orally every 4 hours in combination with background loratadine treatment. | 103 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 4 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Unknown Reason | 5 | 3 | 5 | 7 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | PE 10 mg | PE 20 mg | PE 30 mg | PE 40 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 39.3 years STANDARD_DEVIATION 11.25 | 36.8 years STANDARD_DEVIATION 11.08 | 38.9 years STANDARD_DEVIATION 12.65 | 39.6 years STANDARD_DEVIATION 13.1 | 38.9 years STANDARD_DEVIATION 11.96 | 38.7 years STANDARD_DEVIATION 12.04 |
| Sex: Female, Male Female | 76 Participants | 63 Participants | 73 Participants | 52 Participants | 61 Participants | 325 Participants |
| Sex: Female, Male Male | 33 Participants | 45 Participants | 34 Participants | 60 Participants | 42 Participants | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 109 | 4 / 108 | 3 / 107 | 3 / 112 | 0 / 103 |
| serious Total, serious adverse events | 0 / 109 | 0 / 108 | 0 / 107 | 1 / 112 | 0 / 103 |
Outcome results
Primary
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
Time frame: Baseline, Day 7
Population: The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE 10 mg | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | -0.460 Units on a Scale | Standard Deviation 0.5374 |
| PE 20 mg | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | -0.499 Units on a Scale | Standard Deviation 0.5042 |
| PE 30 mg | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | -0.508 Units on a Scale | Standard Deviation 0.5618 |
| PE 40 mg | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | -0.461 Units on a Scale | Standard Deviation 0.5308 |
| Placebo | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | -0.428 Units on a Scale | Standard Deviation 0.553 |
p-value: 0.4912ANCOVA
p-value: 0.4519ANCOVA
p-value: 0.2186ANCOVA
p-value: 0.5983ANCOVA
Secondary
Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7
The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: Baseline, Day 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PE 10 mg | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | -0.382 Units on a Scale | Standard Deviation 0.833 |
| PE 20 mg | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | -0.376 Units on a Scale | Standard Deviation 0.9258 |
| PE 30 mg | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | -0.408 Units on a Scale | Standard Deviation 0.9176 |
| PE 40 mg | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | -0.404 Units on a Scale | Standard Deviation 0.8591 |
| Placebo | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | -0.380 Units on a Scale | Standard Deviation 0.7625 |
Secondary
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline (n = 109. 108, 106, 111, 102) | 2.394 Units on a Scale | Standard Deviation 0.3869 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.353 Units on a Scale | Standard Deviation 0.5821 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.297 Units on a Scale | Standard Deviation 0.5786 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.451 Units on a Scale | Standard Deviation 0.6566 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.519 Units on a Scale | Standard Deviation 0.6455 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 101) | -0.475 Units on a Scale | Standard Deviation 0.6831 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.543 Units on a Scale | Standard Deviation 0.7267 |
| PE 10 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.576 Units on a Scale | Standard Deviation 0.7385 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.320 Units on a Scale | Standard Deviation 0.5181 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 101) | -0.550 Units on a Scale | Standard Deviation 0.6478 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline (n = 109. 108, 106, 111, 102) | 2.452 Units on a Scale | Standard Deviation 0.3593 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.449 Units on a Scale | Standard Deviation 0.5989 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.367 Units on a Scale | Standard Deviation 0.613 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.573 Units on a Scale | Standard Deviation 0.6821 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.468 Units on a Scale | Standard Deviation 0.6256 |
| PE 20 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.689 Units on a Scale | Standard Deviation 0.7241 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.635 Units on a Scale | Standard Deviation 0.689 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.610 Units on a Scale | Standard Deviation 0.7658 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.441 Units on a Scale | Standard Deviation 0.6548 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 101) | -0.529 Units on a Scale | Standard Deviation 0.7278 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.367 Units on a Scale | Standard Deviation 0.5734 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.431 Units on a Scale | Standard Deviation 0.7168 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline (n = 109. 108, 106, 111, 102) | 2.440 Units on a Scale | Standard Deviation 0.3684 |
| PE 30 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.559 Units on a Scale | Standard Deviation 0.6994 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.389 Units on a Scale | Standard Deviation 0.6408 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.392 Units on a Scale | Standard Deviation 0.5406 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.425 Units on a Scale | Standard Deviation 0.5806 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.520 Units on a Scale | Standard Deviation 0.7017 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 101) | -0.484 Units on a Scale | Standard Deviation 0.6992 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.556 Units on a Scale | Standard Deviation 0.6695 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline (n = 109. 108, 106, 111, 102) | 2.437 Units on a Scale | Standard Deviation 0.3722 |
| PE 40 mg | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.544 Units on a Scale | Standard Deviation 0.7232 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.444 Units on a Scale | Standard Deviation 0.6383 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.490 Units on a Scale | Standard Deviation 0.777 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.345 Units on a Scale | Standard Deviation 0.6239 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.460 Units on a Scale | Standard Deviation 0.6943 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Baseline (n = 109. 108, 106, 111, 102) | 2.457 Units on a Scale | Standard Deviation 0.4014 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 101) | -0.444 Units on a Scale | Standard Deviation 0.6859 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.364 Units on a Scale | Standard Deviation 0.6125 |
| Placebo | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.449 Units on a Scale | Standard Deviation 0.6852 |
Secondary
Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period
Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.271 Units on a Scale | Standard Deviation 0.6669 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 7 (n = 102, 101, 98, 94, 100) | -0.382 Units on a Scale | Standard Deviation 0.833 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 6 (n =102, 102, 98, 95, 100) | -0.353 Units on a Scale | Standard Deviation 0.8402 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 3 (n = 102, 102, 100, 98, 100) | -0.265 Units on a Scale | Standard Deviation 0.9002 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 2 (n = 102, 104, 100, 99, 100) | -0.147 Units on a Scale | Standard Deviation 0.6807 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 4 (n = 102, 102, 99, 97, 100) | -0.324 Units on a Scale | Standard Deviation 0.8462 |
| PE 10 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 5 (n = 102, 102, 99, 95, 100) | -0.304 Units on a Scale | Standard Deviation 0.755 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 5 (n = 102, 102, 99, 95, 100) | -0.314 Units on a Scale | Standard Deviation 0.8672 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 4 (n = 102, 102, 99, 97, 100) | -0.255 Units on a Scale | Standard Deviation 0.8288 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 2 (n = 102, 104, 100, 99, 100) | 0.010 Units on a Scale | Standard Deviation 0.7568 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.311 Units on a Scale | Standard Deviation 0.6527 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 6 (n =102, 102, 98, 95, 100) | -0.422 Units on a Scale | Standard Deviation 0.9589 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 3 (n = 102, 102, 100, 98, 100) | -0.206 Units on a Scale | Standard Deviation 0.7491 |
| PE 20 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 7 (n = 102, 101, 98, 94, 100) | -0.376 Units on a Scale | Standard Deviation 0.9258 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 4 (n = 102, 102, 99, 97, 100) | -0.253 Units on a Scale | Standard Deviation 0.9186 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.298 Units on a Scale | Standard Deviation 0.6809 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 2 (n = 102, 104, 100, 99, 100) | -0.060 Units on a Scale | Standard Deviation 0.7361 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 3 (n = 102, 102, 100, 98, 100) | -0.130 Units on a Scale | Standard Deviation 0.8246 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 5 (n = 102, 102, 99, 95, 100) | -0.283 Units on a Scale | Standard Deviation 0.8456 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 6 (n =102, 102, 98, 95, 100) | -0.337 Units on a Scale | Standard Deviation 0.8961 |
| PE 30 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 7 (n = 102, 101, 98, 94, 100) | -0.408 Units on a Scale | Standard Deviation 0.9176 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 3 (n = 102, 102, 100, 98, 100) | -0.112 Units on a Scale | Standard Deviation 0.8234 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 5 (n = 102, 102, 99, 95, 100) | -0.232 Units on a Scale | Standard Deviation 0.8927 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 2 (n = 102, 104, 100, 99, 100) | -0.010 Units on a Scale | Standard Deviation 0.6308 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 7 (n = 102, 101, 98, 94, 100) | -0.404 Units on a Scale | Standard Deviation 0.8591 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 6 (n =102, 102, 98, 95, 100) | -0.379 Units on a Scale | Standard Deviation 0.8013 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.311 Units on a Scale | Standard Deviation 0.6228 |
| PE 40 mg | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 4 (n = 102, 102, 99, 97, 100) | -0.351 Units on a Scale | Standard Deviation 0.8421 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 3 (n = 102, 102, 100, 98, 100) | -0.130 Units on a Scale | Standard Deviation 0.774 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 7 (n = 102, 101, 98, 94, 100) | -0.380 Units on a Scale | Standard Deviation 0.7625 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 6 (n =102, 102, 98, 95, 100) | -0.260 Units on a Scale | Standard Deviation 0.7333 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 5 (n = 102, 102, 99, 95, 100) | -0.240 Units on a Scale | Standard Deviation 0.698 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 2 (n = 102, 104, 100, 99, 100) | -0.180 Units on a Scale | Standard Deviation 0.7572 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.406 Units on a Scale | Standard Deviation 0.603 |
| Placebo | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Day 4 (n = 102, 102, 99, 97, 100) | -0.280 Units on a Scale | Standard Deviation 0.8297 |
Secondary
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period
Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 103, 101, 99, 101) | -0.304 Units on a Scale | Standard Deviation 0.755 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 103,101,101, 101) | -0.324 Units on a Scale | Standard Deviation 0.8462 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.382 Units on a Scale | Standard Deviation 0.833 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 99, 100) | -0.353 Units on a Scale | Standard Deviation 0.8402 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 103, 102, 102, 101) | -0.265 Units on a Scale | Standard Deviation 0.9002 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 105, 102, 103, 101) | -0.147 Units on a Scale | Standard Deviation 0.6807 |
| PE 10 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.271 Units on a Scale | Standard Deviation 0.6669 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 105, 102, 103, 101) | 0.010 Units on a Scale | Standard Deviation 0.7568 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 103,101,101, 101) | -0.255 Units on a Scale | Standard Deviation 0.8288 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.376 Units on a Scale | Standard Deviation 0.9258 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 103, 101, 99, 101) | -0.314 Units on a Scale | Standard Deviation 0.8672 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.311 Units on a Scale | Standard Deviation 0.6527 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 99, 100) | -0.422 Units on a Scale | Standard Deviation 0.9589 |
| PE 20 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 103, 102, 102, 101) | -0.206 Units on a Scale | Standard Deviation 0.7491 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 99, 100) | -0.337 Units on a Scale | Standard Deviation 0.8961 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.298 Units on a Scale | Standard Deviation 0.6809 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 105, 102, 103, 101) | -0.060 Units on a Scale | Standard Deviation 0.7361 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 103, 102, 102, 101) | -0.130 Units on a Scale | Standard Deviation 0.8246 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 103,101,101, 101) | -0.253 Units on a Scale | Standard Deviation 0.9186 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 103, 101, 99, 101) | -0.283 Units on a Scale | Standard Deviation 0.8456 |
| PE 30 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.408 Units on a Scale | Standard Deviation 0.9176 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 99, 100) | -0.379 Units on a Scale | Standard Deviation 0.8013 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 103, 101, 99, 101) | -0.232 Units on a Scale | Standard Deviation 0.8927 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 103, 102, 102, 101) | -0.112 Units on a Scale | Standard Deviation 0.8234 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.311 Units on a Scale | Standard Deviation 0.6228 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.404 Units on a Scale | Standard Deviation 0.8591 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 103,101,101, 101) | -0.351 Units on a Scale | Standard Deviation 0.8421 |
| PE 40 mg | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 105, 102, 103, 101) | -0.010 Units on a Scale | Standard Deviation 0.6308 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 103,101,101, 101) | -0.280 Units on a Scale | Standard Deviation 0.8297 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 103, 101, 99, 101) | -0.240 Units on a Scale | Standard Deviation 0.698 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 105, 102, 103, 101) | -0.180 Units on a Scale | Standard Deviation 0.7572 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 99, 100) | -0.260 Units on a Scale | Standard Deviation 0.7333 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 107, 106, 104, 106, 101) | 2.406 Units on a Scale | Standard Deviation 0.603 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.380 Units on a Scale | Standard Deviation 0.7625 |
| Placebo | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 103, 102, 102, 101) | -0.130 Units on a Scale | Standard Deviation 0.774 |
Secondary
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, and 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.376 Units on a Scale | Standard Deviation 0.4521 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.321 Units on a Scale | Standard Deviation 0.6107 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 102, 103, 102, 103, 101) | -0.360 Units on a Scale | Standard Deviation 0.724 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 101, 101, 101) | -0.546 Units on a Scale | Standard Deviation 0.7289 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 99, 100) | -0.536 Units on a Scale | Standard Deviation 0.7524 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 102, 97, 99, 99) | -0.526 Units on a Scale | Standard Deviation 0.7398 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 103, 100, 100, 100) | -0.613 Units on a Scale | Standard Deviation 0.8539 |
| PE 10 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.613 Units on a Scale | Standard Deviation 0.792 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 102, 103, 102, 103, 101) | -0.410 Units on a Scale | Standard Deviation 0.665 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 102, 97, 99, 99) | -0.610 Units on a Scale | Standard Deviation 0.7863 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.361 Units on a Scale | Standard Deviation 0.4577 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 101, 101, 101) | -0.512 Units on a Scale | Standard Deviation 0.7049 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.285 Units on a Scale | Standard Deviation 0.5961 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.650 Units on a Scale | Standard Deviation 0.7766 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 99, 100) | -0.474 Units on a Scale | Standard Deviation 0.7479 |
| PE 20 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 103, 100, 100, 100) | -0.750 Units on a Scale | Standard Deviation 0.8105 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 103, 100, 100, 100) | -0.648 Units on a Scale | Standard Deviation 0.8624 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.588 Units on a Scale | Standard Deviation 0.9323 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 101, 101, 101) | -0.527 Units on a Scale | Standard Deviation 0.844 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 102, 97, 99, 99) | -0.564 Units on a Scale | Standard Deviation 0.9052 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 102, 103, 102, 103, 101) | -0.483 Units on a Scale | Standard Deviation 0.8177 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.359 Units on a Scale | Standard Deviation 0.7701 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.363 Units on a Scale | Standard Deviation 0.4514 |
| PE 30 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 99, 100) | -0.597 Units on a Scale | Standard Deviation 0.8653 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.321 Units on a Scale | Standard Deviation 0.6852 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 102, 103, 102, 103, 101) | -0.466 Units on a Scale | Standard Deviation 0.7646 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 101, 101, 101) | -0.480 Units on a Scale | Standard Deviation 0.7346 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 99, 100) | -0.533 Units on a Scale | Standard Deviation 0.8227 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 102, 97, 99, 99) | -0.475 Units on a Scale | Standard Deviation 0.7739 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.564 Units on a Scale | Standard Deviation 0.7752 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.362 Units on a Scale | Standard Deviation 0.4476 |
| PE 40 mg | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 103, 100, 100, 100) | -0.597 Units on a Scale | Standard Deviation 0.8704 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 101, 101, 101) | -0.505 Units on a Scale | Standard Deviation 0.7818 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 102, 100, 98, 100) | -0.520 Units on a Scale | Standard Deviation 0.8781 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 102, 103, 102, 103, 101) | -0.386 Units on a Scale | Standard Deviation 0.7988 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 103, 100, 100, 100) | -0.470 Units on a Scale | Standard Deviation 0.8515 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.380 Units on a Scale | Standard Deviation 0.4846 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 102, 97, 99, 99) | -0.485 Units on a Scale | Standard Deviation 0.887 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 1 (n = 102, 106, 101, 102, 101) | -0.287 Units on a Scale | Standard Deviation 0.7003 |
| Placebo | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 99, 100) | -0.450 Units on a Scale | Standard Deviation 0.8142 |
Secondary
Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period
The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time frame: Baseline and Days 2, 3, 4, 5, 6, and 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.417 Units on a Scale | Standard Deviation 0.4327 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.541 Units on a Scale | Standard Deviation 0.8543 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.474 Units on a Scale | Standard Deviation 0.7751 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.359 Units on a Scale | Standard Deviation 0.775 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.243 Units on a Scale | Standard Deviation 0.6034 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.503 Units on a Scale | Standard Deviation 0.7604 |
| PE 10 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 100) | -0.426 Units on a Scale | Standard Deviation 0.7881 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 100) | -0.458 Units on a Scale | Standard Deviation 0.7118 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.439 Units on a Scale | Standard Deviation 0.7179 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.200 Units on a Scale | Standard Deviation 0.594 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.517 Units on a Scale | Standard Deviation 0.3995 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.612 Units on a Scale | Standard Deviation 0.8283 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.362 Units on a Scale | Standard Deviation 0.6883 |
| PE 20 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.472 Units on a Scale | Standard Deviation 0.8186 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.485 Units on a Scale | Standard Deviation 0.7318 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.481 Units on a Scale | Standard Deviation 0.4148 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.216 Units on a Scale | Standard Deviation 0.6416 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.324 Units on a Scale | Standard Deviation 0.7109 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 100) | -0.465 Units on a Scale | Standard Deviation 0.7365 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.584 Units on a Scale | Standard Deviation 0.7866 |
| PE 30 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.594 Units on a Scale | Standard Deviation 0.8256 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.369 Units on a Scale | Standard Deviation 0.6679 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 100) | -0.474 Units on a Scale | Standard Deviation 0.7762 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.308 Units on a Scale | Standard Deviation 0.663 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.539 Units on a Scale | Standard Deviation 0.7858 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.474 Units on a Scale | Standard Deviation 0.7525 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.492 Units on a Scale | Standard Deviation 0.3887 |
| PE 40 mg | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.510 Units on a Scale | Standard Deviation 0.7924 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 3 (n = 104, 104, 102, 103, 101) | -0.362 Units on a Scale | Standard Deviation 0.6834 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 7 (n = 104, 103, 100, 99, 100) | -0.438 Units on a Scale | Standard Deviation 0.8296 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 6 (n = 104, 104, 100, 100, 100) | -0.428 Units on a Scale | Standard Deviation 0.7331 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 5 (n = 104, 104, 101, 100, 100) | -0.392 Units on a Scale | Standard Deviation 0.7236 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 2 (n = 104, 106, 102, 104, 101) | -0.283 Units on a Scale | Standard Deviation 0.6439 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Baseline (n = 109, 108, 106, 111, 102) | 2.514 Units on a Scale | Standard Deviation 0.4208 |
| Placebo | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | Day 4 (n = 104, 104, 101, 102, 101) | -0.422 Units on a Scale | Standard Deviation 0.7402 |
Secondary
Time to Maximal Effect
Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.
Time frame: Baseline up to Day 7
Population: The ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PE 10 mg | Time to Maximal Effect | 5.5 Days |
| PE 20 mg | Time to Maximal Effect | 5.5 Days |
| PE 30 mg | Time to Maximal Effect | 5.5 Days |
| PE 40 mg | Time to Maximal Effect | 5.5 Days |