Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
Condition: Rhinitis; Seasonal Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Phenylephrine HCl; Placebo; Loratadine
Intervention description: 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days; Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days; 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.
Intervention MeSH terms: Loratadine; Phenylephrine; Oxymetazoline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 539.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Seasonal allergies

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.
    

Eligibility criteria:

        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.