This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover
study, conducted at a single site in Austria, outside of the normal grass pollen season. An
allergic reaction will be induced by exposing subjects to grass pollen in the Vienna
Challenge Chamber (VCC). Subjects will receive a single dose of each of the following
treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release
capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be
a minimum of a 5-day washout period between each treatment. Subjects will complete symptom
evaluations throughout the study. The nasal decongestant effects of phenylephrine will be
compared to those of placebo using the subjective symptom evaluations. The safety profile
(adverse events and vital signs) of the treatments will also be evaluated.
Inclusion Criteria:
- Ages between 18 and 55 years, of either sex, and of any race.
- A history of SAR for at least 2 years, as diagnosed by the investigator, another
physician, or subject-provided history.
- The following minimum scores at some point during each of the 120-minute screening
period challenge sessions:
- Score of at least 2 (moderate) for nasal congestion.
- Score of at least 6 for combined nasal symptoms (symptoms are rhinorrhea, nasal
congestion, sneezing, nasal itching).
- Score of at least 2 for combined non-nasal symptoms (symptoms are eye
itching/burning, eye tearing, itching of ears/palate).
- Positive skin prick test to relevant grass allergen to be used in the chamber, unless
previously done within 12 months. IgE-mediated hypersensitivity to the appropriate
allergen must be documented by a positive response to the skin prick test with wheal
diameter >=3 mm larger than diluent control.
- A negative urine pregnancy test prior to treatment with study medication for all
female subjects of childbearing potential and a negative urine pregnancy test obtained
at monthly intervals during study participation.
- Use of a medically accepted method of birth control, ie, double-barrier method (eg,
condom and spermicide), oral contraceptive, Depo-Provera or Norplant, for female
subjects of childbearing potential prior to screening and during the study. Women of
childbearing potential should be counseled in the appropriate use of birth control
while in the study. Vasectomy or tubal ligation is considered a single barrier.
Women who are not currently sexually active must agree and consent to use one of the
above-mentioned methods if they become sexually active while participating in the
study.
- Good health and freedom from any clinically significant disease (other than SAR) that
would interfere with the study schedule or procedures, or compromise the subject’s
safety.
- Willingness to give written informed consent and adhere to dose and visit schedules.
- The appropriate washout times from the prohibited medications.
- Clinical laboratory tests (CBC, blood chemistries, urinalysis, and ECG results) at
screening within normal limits or clinically acceptable to the investigator
Exclusion Criteria :
- Pregnancy, intention of becoming pregnant, or lactation.
- A situation or any condition that, in the opinion of the investigator, may interfere
with optimal participation in the study.
- Use of any investigational drugs, including placebo, within 30 days of Screening.
- Current participation in any other clinical study.
- Staff personnel directly involved with this study.
- Dependence (in the opinion of the investigator) upon nasal, oral, or ocular
decongestants, nasal topical antihistamines, or nasal steroids.
- Nasal structural abnormalities, including large nasal polyps or marked septal
deviation, that significantly interfere with nasal airflow.
- Previous enrollment (ie, signed informed consent) into this study.
- History of rhinitis medicamentosa.
- A history of anaphylaxis or severe or serious reaction to skin testing.
- A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the
study drugs or excipients.
- Narrow-angle glaucoma, increased intraocular pressure, urinary retention,
hypertension, severe coronary artery disease, ischemic heart disease, diabetes
mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy, and current
treatment with monoamine oxidase (MAO) inhibitors.
- An upper or lower respiratory tract infection within 4 weeks before screening, or a
respiratory infection any time during the treatment phase of the study.
