Seasonal Allergic Rhinitis
Conditions
Keywords
Nasal Decongestants, Rhinitis, Allergic, Seasonal, Rhinitis, Nose Conditions, Respiratory Tract Diseases, Phenylephrine
Brief summary
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.
Interventions
DRUGPhenylephrine
Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days
DRUGPlacebo
Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days
DRUGLoratadine
Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms
Sponsors
Bayer
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
* Understands study procedures and agrees to participate by giving signed consent form * Male or female, aged 18 years or older, at the Screening Visit. * Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following: * hormonal contraceptives (with documented use for at least 30 days prior to Screening ) * intrauterine device (IUD) * diaphragm with spermicide * contraceptive sponge * condom * vasectomy * Willing to stop use of current decongestant and allergy medications during the trial * Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years and documented or self-reported symptoms over at least the last 2 fall allergy seasons * Documented skin testing (prick with wheal ≥3 mm larger than the diluent or intradermal with wheal ≥7 mm larger than the diluent control) within the last 4 years to fall pollen allergens present and prevalent in his/her geographic region. * Signs and symptoms of nasal congestion (defined as stuffy or blocked nose) of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) following the washout period (if applicable). Participant's diary evaluation must document at least mild symptoms for reflective and instantaneous scores on 4 consecutive days prior to randomization. * Mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg. * Clinically acceptable physical exam and 12-lead ECG (recorded at 25 mm/s) that is clinically acceptable to the investigator. * Free of any clinically significant disease that requires a physician's care and/or would interfere with trial evaluations, procedures, or participation. * Agrees not to take monoamine oxidase inhibitors (MAOIs) from 14 days before trial participation until 14 days after the last dose of study drug. * Capable of reading English.
Exclusion criteria
\- Significant medical condition that is a contraindication to the use of phenylephrine, might interfere with the trial, or requires treatment expected to affect blood pressure * History or presence of hypertension * Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during the trial, or anticipates immunotherapy dose change during the trial * Used Xolair (omalizumab) within 4 years prior to trial participation * Known allergy or intolerance to phenylephrine, loratadine, or desloratadine * History of rhinitis medicamentosa * Documented evidence of acute or significant chronic sinusitis * Clinically significant nasal disorders such as deviated septum and nasal polyposis * Asthma, with the exception of mild intermittent asthma * Have used systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone permitted), or nasal corticosteroids in the last 30 days * Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder over the last 5 years. Those who have had situational depression may be enrolled in the study at the discretion of the investigator. * 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. * History of immunological disease or cancer within the past 5 years, with the exception of nonmelanoma skin cancer * Positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator). * Major surgery or participation in another investigational study within 30 days prior to the Screening Visit. * Body mass index (BMI) ≥ 40
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
| Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Days 1-7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period. |
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, and 7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period. |
| Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period. |
| Time to Maximal Phenylephrine Effect | Baseline up to Day 7 | The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group. |
| Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Day 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period. |
| Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
| Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline and Day 2, 3, 4, 5, 6, and 7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period. |
| Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Baseline and Day 1, 2, 3, 4, 5, 6, and 7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period. |
| Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Baseline and Day 2, 3, 4, 5, 6, and 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period. |
| Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline and Day 1, 2, 3, 4, 5, 6, and 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period. |
| Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) | Up to Day 8 | The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3 questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains. |
| Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Baseline and Days 1-7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period. |
Participant flow
Recruitment details
29 centers in the United States; Study Period: August 2011 to October 2011
Participants by arm
| Arm | Count |
|---|---|
| Phenylephrine Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days | 288 |
| Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days | 287 |
| Total | 575 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Phenylephrine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 11.64 | 40.1 years STANDARD_DEVIATION 11.62 | 40.1 years STANDARD_DEVIATION 11.62 |
| Sex: Female, Male Female | 176 Participants | 177 Participants | 353 Participants |
| Sex: Female, Male Male | 112 Participants | 110 Participants | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 288 | 0 / 287 |
| serious Total, serious adverse events | 0 / 288 | 0 / 287 |
Outcome results
Primary
Mean Change From Baseline in Daily Reflective Nasal Congestion Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Time frame: Baseline and Days 1-7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Baseline | 2.357 Scores on a scale | Standard Deviation 0.5203 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Change from Baseline for Entire Treatment Period | -0.394 Scores on a scale | Standard Deviation 0.488 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Baseline | 2.271 Scores on a scale | Standard Deviation 0.5586 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Change from Baseline for Entire Treatment Period | -0.412 Scores on a scale | Standard Deviation 0.5383 |
Secondary
Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.
Time frame: Baseline and Day 7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline | 2.299 Scores on a scale | Standard Deviation 0.525 |
| Phenylephrine | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Day 7 | -0.352 Scores on a scale | Standard Deviation 0.6698 |
| Placebo | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline | 2.225 Scores on a scale | Standard Deviation 0.5498 |
| Placebo | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Day 7 | -0.476 Scores on a scale | Standard Deviation 0.7829 |
Secondary
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Population: Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline | 2.300 Scores on a scale | Standard Deviation 0.5612 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 1 | -0.193 Scores on a scale | Standard Deviation 0.5888 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 2 | -0.344 Scores on a scale | Standard Deviation 0.6768 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 3 | -0.349 Scores on a scale | Standard Deviation 0.7591 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 4 | -0.395 Scores on a scale | Standard Deviation 0.7529 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 5 | -0.408 Scores on a scale | Standard Deviation 0.7558 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 6 | -0.424 Scores on a scale | Standard Deviation 0.7584 |
| Phenylephrine | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 7 | -0.401 Scores on a scale | Standard Deviation 0.7865 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 7 | -0.495 Scores on a scale | Standard Deviation 0.8645 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline | 2.189 Scores on a scale | Standard Deviation 0.5878 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 4 | -0.434 Scores on a scale | Standard Deviation 0.8079 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 1 | -0.164 Scores on a scale | Standard Deviation 0.6415 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 6 | -0.497 Scores on a scale | Standard Deviation 0.8122 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 2 | -0.332 Scores on a scale | Standard Deviation 0.702 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 5 | -0.430 Scores on a scale | Standard Deviation 0.7714 |
| Placebo | Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. | Day 3 | -0.378 Scores on a scale | Standard Deviation 0.7773 |
Secondary
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Baseline | 2.353 Scores on a scale | Standard Deviation 0.547 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 1 | -0.257 Scores on a scale | Standard Deviation 0.585 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 2 | -0.343 Scores on a scale | Standard Deviation 0.6732 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 3 | -0.402 Scores on a scale | Standard Deviation 0.72 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 4 | -0.420 Scores on a scale | Standard Deviation 0.7294 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 5 | -0.475 Scores on a scale | Standard Deviation 0.7154 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 6 | -0.463 Scores on a scale | Standard Deviation 0.7593 |
| Phenylephrine | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 7 | -0.464 Scores on a scale | Standard Deviation 0.7813 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 7 | -0.528 Scores on a scale | Standard Deviation 0.8802 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Baseline | 2.261 Scores on a scale | Standard Deviation 0.5932 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 4 | -0.511 Scores on a scale | Standard Deviation 0.818 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 1 | -0.187 Scores on a scale | Standard Deviation 0.6583 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 6 | -0.509 Scores on a scale | Standard Deviation 0.8143 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 2 | -0.362 Scores on a scale | Standard Deviation 0.6729 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 5 | -0.470 Scores on a scale | Standard Deviation 0.7997 |
| Placebo | Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period | Day 3 | -0.404 Scores on a scale | Standard Deviation 0.7336 |
Secondary
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 3 | -0.285 Scores on a scale | Standard Deviation 0.6888 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 5 | -0.326 Scores on a scale | Standard Deviation 0.7201 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 2 | -0.188 Scores on a scale | Standard Deviation 0.568 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 6 | -0.327 Scores on a scale | Standard Deviation 0.7128 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 4 | -0.326 Scores on a scale | Standard Deviation 0.7035 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 7 | -0.319 Scores on a scale | Standard Deviation 0.7488 |
| Phenylephrine | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Baseline | 2.313 Scores on a scale | Standard Deviation 0.5518 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 7 | -0.462 Scores on a scale | Standard Deviation 0.8618 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Baseline | 2.264 Scores on a scale | Standard Deviation 0.5816 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 2 | -0.185 Scores on a scale | Standard Deviation 0.6511 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 3 | -0.373 Scores on a scale | Standard Deviation 0.7389 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 4 | -0.383 Scores on a scale | Standard Deviation 0.768 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 5 | -0.387 Scores on a scale | Standard Deviation 0.7617 |
| Placebo | Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period | Day 6 | -0.394 Scores on a scale | Standard Deviation 0.8314 |
Secondary
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 2, 3, 4, 5, 6, and 7
Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 3 | -0.402 Scores on a scale | Standard Deviation 0.6723 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 5 | -0.451 Scores on a scale | Standard Deviation 0.7214 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 2 | -0.263 Scores on a scale | Standard Deviation 0.5769 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 6 | -0.456 Scores on a scale | Standard Deviation 0.7425 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 4 | -0.367 Scores on a scale | Standard Deviation 0.7147 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 7 | -0.478 Scores on a scale | Standard Deviation 0.783 |
| Phenylephrine | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline | 2.357 Scores on a scale | Standard Deviation 0.548 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 7 | -0.489 Scores on a scale | Standard Deviation 0.8515 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline | 2.274 Scores on a scale | Standard Deviation 0.5801 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 2 | -0.273 Scores on a scale | Standard Deviation 0.6685 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 3 | -0.380 Scores on a scale | Standard Deviation 0.6932 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 4 | -0.469 Scores on a scale | Standard Deviation 0.7482 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 5 | -0.480 Scores on a scale | Standard Deviation 0.7631 |
| Placebo | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Day 6 | -0.462 Scores on a scale | Standard Deviation 0.8294 |
Secondary
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.
Time frame: Baseline and Days 1-7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline | 2.299 Scores on a scale | Standard Deviation 0.525 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Entire Treatment Period | -0.311 Scores on a scale | Standard Deviation 0.4663 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline | 2.225 Scores on a scale | Standard Deviation 0.5498 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Entire Treatment Period | -0.366 Scores on a scale | Standard Deviation 0.5265 |
Secondary
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, 7
Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Baseline | 2.299 Scores on a scale | Standard Deviation 0.525 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 1 | -0.192 Scores on a scale | Standard Deviation 0.5809 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 2 | -0.255 Scores on a scale | Standard Deviation 0.5046 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 3 | -0.307 Scores on a scale | Standard Deviation 0.6206 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 4 | -0.351 Scores on a scale | Standard Deviation 0.6133 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 5 | -0.359 Scores on a scale | Standard Deviation 0.6432 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 6 | -0.361 Scores on a scale | Standard Deviation 0.6582 |
| Phenylephrine | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 7 | -0.352 Scores on a scale | Standard Deviation 0.6698 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 7 | -0.476 Scores on a scale | Standard Deviation 0.7829 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Baseline | 2.225 Scores on a scale | Standard Deviation 0.5498 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 4 | -0.406 Scores on a scale | Standard Deviation 0.6881 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 1 | -0.200 Scores on a scale | Standard Deviation 0.6451 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 6 | -0.443 Scores on a scale | Standard Deviation 0.7336 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 2 | -0.256 Scores on a scale | Standard Deviation 0.5472 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 5 | -0.406 Scores on a scale | Standard Deviation 0.6632 |
| Placebo | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Day 3 | -0.373 Scores on a scale | Standard Deviation 0.6548 |
Secondary
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.
Time frame: Baseline and Day 1, 2, 3, 4, 5, 6, and 7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Baseline | 2.357 Scores on a scale | Standard Deviation 0.5203 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 1 | -0.261 Scores on a scale | Standard Deviation 0.5545 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 2 | -0.302 Scores on a scale | Standard Deviation 0.5248 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 3 | -0.401 Scores on a scale | Standard Deviation 0.61 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 4 | -0.395 Scores on a scale | Standard Deviation 0.6234 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 5 | -0.465 Scores on a scale | Standard Deviation 0.6475 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 6 | -0.461 Scores on a scale | Standard Deviation 0.6918 |
| Phenylephrine | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 7 | -0.474 Scores on a scale | Standard Deviation 0.7116 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 7 | -0.512 Scores on a scale | Standard Deviation 0.7903 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Baseline | 2.271 Scores on a scale | Standard Deviation 0.5586 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 4 | -0.492 Scores on a scale | Standard Deviation 0.6942 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 1 | -0.197 Scores on a scale | Standard Deviation 0.6335 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 6 | -0.488 Scores on a scale | Standard Deviation 0.7444 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 2 | -0.321 Scores on a scale | Standard Deviation 0.5721 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 5 | -0.478 Scores on a scale | Standard Deviation 0.6977 |
| Placebo | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Day 3 | -0.396 Scores on a scale | Standard Deviation 0.6227 |
Secondary
Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score
The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.
Time frame: Baseline and Days 1-7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Baseline | 2.313 Scores on a scale | Standard Deviation 0.5518 |
| Phenylephrine | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Entire Treatment Period | -0.295 Scores on a scale | Standard Deviation 0.5088 |
| Placebo | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Baseline | 2.264 Scores on a scale | Standard Deviation 0.5816 |
| Placebo | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Entire Treatment Period | -0.363 Scores on a scale | Standard Deviation 0.5815 |
Secondary
Mean Change From Baseline in the Evening Reflective Symptom Assessment Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Time frame: Baseline and Days 1-7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Baseline | 2.353 Scores on a scale | Standard Deviation 0.547 |
| Phenylephrine | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Entire Treatment Period | -0.403 Scores on a scale | Standard Deviation 0.5424 |
| Placebo | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Baseline | 2.261 Scores on a scale | Standard Deviation 0.5932 |
| Placebo | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Entire Treatment Period | -0.424 Scores on a scale | Standard Deviation 0.5894 |
Secondary
Mean Change From Baseline in the Morning Reflective Symptom Assessment Score
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
Time frame: Baseline and Days 1-7
Population: Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Baseline | 2.357 Scores on a scale | Standard Deviation 0.548 |
| Phenylephrine | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Entire Treatment Period | -0.403 Scores on a scale | Standard Deviation 0.542 |
| Placebo | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Baseline | 2.274 Scores on a scale | Standard Deviation 0.5801 |
| Placebo | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Entire Treatment Period | -0.425 Scores on a scale | Standard Deviation 0.5868 |
Secondary
Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)
The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3 questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains.
Time frame: Up to Day 8
Population: The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenylephrine | Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) | Baseline | 3.6 Scores on a scale | Standard Deviation 1.28 |
| Phenylephrine | Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) | Day 8 | -0.8 Scores on a scale | Standard Deviation 1.15 |
| Placebo | Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) | Baseline | 3.5 Scores on a scale | Standard Deviation 1.28 |
| Placebo | Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) | Day 8 | -0.9 Scores on a scale | Standard Deviation 1.13 |
Secondary
Time to Maximal Phenylephrine Effect
The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.
Time frame: Baseline up to Day 7
Population: All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenylephrine | Time to Maximal Phenylephrine Effect | 0.5 Days |