Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Dose-ranging, Placebo-controlled Trial to Evaluate the Effects of Phenylephrine HCl Immediate Release Tablets on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis

Conditions
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Rhinitis, Seasonal Rhinitis

Intervention / Treatment
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* Drug: Phenylephrine HCl
* Drug: Placebo
* Drug: Loratadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PE 10 mg<br> | Drug: Phenylephrine HCl<br>* 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days<br>* Other names: SCH 002063;Drug: Placebo<br>* Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days<br>Drug: Loratadine<br>* 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.<br>* Other names: Claritin®;|
| Experimental: PE 20 mg<br> | Drug: Phenylephrine HCl<br>* 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days<br>* Other names: SCH 002063;Drug: Placebo<br>* Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days<br>Drug: Loratadine<br>* 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.<br>* Other names: Claritin®;|
| Experimental: PE 30 mg<br> | Drug: Phenylephrine HCl<br>* 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days<br>* Other names: SCH 002063;Drug: Placebo<br>* Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days<br>Drug: Loratadine<br>* 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.<br>* Other names: Claritin®;|
| Experimental: PE 40 mg<br> | Drug: Phenylephrine HCl<br>* 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days<br>* Other names: SCH 002063;Drug: Placebo<br>* Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days<br>Drug: Loratadine<br>* 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.<br>* Other names: Claritin®;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days<br>Drug: Loratadine<br>* 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.<br>* Other names: Claritin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Days 2, 3, 4, 5, 6, and 7 | 
| 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. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | 
| 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. | Baseline and Day 2, 3, 4, 5, 6, and 7 | 
| 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. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | 
| 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. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 | 
| 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. | Baseline up to Day 7 | 
| 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. | Baseline, Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seasonal allergies