Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Phenylephrine; Placebo; Loratadine
Intervention description: Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days; Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days; Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms
Intervention MeSH terms: Loratadine; Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 575.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nasal Decongestants; Rhinitis, Allergic, Seasonal; Rhinitis; Nose Conditions; Respiratory Tract Diseases; Phenylephrine

Summary:

      This study will compare the nasal congestion symptom relief of phenylephrine extended release
      tablets and placebo in participants with allergic rhinitis.
    

Eligibility criteria:

        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