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

Last updated: February 7, 2022
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT03855228
C94-145
C94-145
  • Ages > 12
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 2-year history of seasonal allergic rhinitis
  • Positive skin test response to a local seasonal allergen (current, or performed ininvestigator's office within the past year)
  • Good health and free of any unstable, clinically significant disease, other thanallergic rhinitis, that would interfere with the study schedule or evaluation ofseasonal allergic rhinitis

Exclusion

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 otherdisorder 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 allergicrhinitis
  • Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaledbronchodilators are permitted for asthma treatment)
  • Current or history of frequent, clinically significant sinusitis or chronic purulentpostnasal drip
  • Upper respiratory tract or sinus infection that requires antibiotic therapy within theprevious 2 weeks, or a viral upper respiratory infection (URI) within the 7 days priorto 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 septaldeviation, that significantly interfere with nasal air flow
  • Immunotherapy (desensitization therapy), unless on a stable maintenance schedule forat 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, orany other emotional or intellectual problems that are likely to limit the validity ofconsent to participate in the study

Study Design

Total Participants: 704
Study Start date:
March 01, 1995
Estimated Completion Date:
August 07, 1995