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The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR) (Study P04579)(COMPLETED)
This study has been completed.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00276016
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: phenylephrine, pseudoephedrine
Phase III

MedlinePlus related topics: Hay Fever
Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Ephedrine Ephedrine Hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine Sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber

Further study details as provided by Schering-Plough:

Estimated Enrollment: 39
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276016

Sponsors and Collaborators
Schering-Plough
Investigators
Principal Investigator: May Not Be Revealed May Not Be Revealed
  More Information

Study ID Numbers: P04579
Study First Received: January 11, 2006
Last Updated: November 2, 2006
ClinicalTrials.gov Identifier: NCT00276016  
Health Authority: Austria: Federal Ministry for Health and Women

Study placed in the following topic categories:
Pseudoephedrine
Otorhinolaryngologic Diseases
SARS
Rhinitis
Naphazoline
Oxymetazoline
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Guaifenesin
Phenylephrine
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Ephedrine
Phenylpropanolamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Cardiotonic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Nasal Decongestants
Therapeutic Uses
Vasoconstrictor Agents
Appetite Depressants
Adrenergic alpha-Agonists
Immune System Diseases
Sympathomimetics
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Nose Diseases
Anti-Obesity Agents
Mydriatics
Autonomic Agents
Expectorants
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009