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Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423995
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : February 16, 2022
Information provided by (Responsible Party):
Organon and Co

Brief Summary:
This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded. During the priming visit(s), subjects will be evaluated to determine if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects will complete symptom evaluations and if qualified, they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated. Adverse events will be collected throughout the study to assess safety and tolerability, and vital signs will be collected at Visit 1 and at the end of Visit 3.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Loratadine/montelukast combination Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Decongestant Effect of the Combination of Loratadine and Montelukast Compared With Placebo in SAR Subjects Exposed to Pollen in an Environmental Exposure Unit
Actual Study Start Date : November 1, 2006
Actual Primary Completion Date : March 1, 2007
Actual Study Completion Date : March 10, 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18 years or greater, of either sex, any race.
  • A history of SAR due to ragweed for at least two consecutive ragweed seasons, as diagnosed by the investigator, another physician, or subject-provided history.
  • Positive skin prick test to ragweed allergen to be used in the EEU, unless previously done within 12 months
  • Minimum scores (diary evaluation time) must be achieved during pollen exposure during both a Priming Visit and the Treatment Visit:
  • A negative urine pregnancy test at Screening and prior to randomization at the Treatment Visit for all female subjects of childbearing potential.
  • Use of a medically accepted method of birth control.
  • In the judgment of the investigator, 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.
  • The appropriate washout times from the prohibited medications.

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 and for the duration of the study.
  • 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 cause greater than 50% obstruction of 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; current treatment with monoamine oxidase (MAO) inhibitors.
  • An upper or lower respiratory tract infection within 28 days (4 weeks) before Priming (Visit 2) and thereafter.).
  • History of a positive test for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or C.
  • Asthma that requires medication other than occasional (<= 3 uses per week) use of an inhaled short-acting beta-2 agonist.
Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
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Responsible Party: Organon and Co Identifier: NCT00423995    
Other Study ID Numbers: P04822
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents