Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Organon and Co704 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

704

Conditions

Rhinitis, Allergic

Interventions

Mometasone furoate nasal spray (MFNS)DRUG

Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.

LoratadineDRUG

Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.

Placebo nasal sprayDRUG

Daily dose of placebo administered as a nasal spray for 15 days.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 2-year history of seasonal allergic rhinitis * Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year) * Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis Exclusion Criteria: * Women who are pregnant or breastfeeding * Women of childbearing potential who are not using an acceptable form of birth control * Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study * Use of any chronic medication which could affect the course of seasonal allergic rhinitis * Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment) * Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip * Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening * Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator * Has rhinitis medicamentosa * Evidence of clinically significant nasal candidiasis * Investigational drug use within the previous 30 days * Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow * Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit * History of multiple drug allergies, allergy to antihistamines or corticoids * History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study

Outcomes

Primary Outcomes

Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)

Change From Baseline in Total Symptom Score (Assessed by Participant)

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)

Secondary Outcomes

Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)

Data from ClinicalTrials.gov

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