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

NCT ID: NCT03855228

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 704 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-03-01
• Study Completion Date: 1995-08-07

Brief 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.

Conditions

Rhinitis, Allergic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MFNS 200 µg + Loratadine 10 mg

Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.

Group Type: EXPERIMENTAL

Mometasone furoate nasal spray (MFNS)

Intervention Type: DRUG

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

Loratadine

Intervention Type: DRUG

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

MFNS 200 µg

Daily administration of 200 µg of MFNS plus oral placebo tablet.

Group Type: ACTIVE_COMPARATOR

Mometasone furoate nasal spray (MFNS)

Intervention Type: DRUG

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

Placebo tablet

Intervention Type: DRUG

Daily dose of placebo administered as an oral tablet for 15 days.

Loratadine 10 mg

Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.

Group Type: ACTIVE_COMPARATOR

Loratadine

Intervention Type: DRUG

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

Placebo nasal spray

Intervention Type: DRUG

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

Placebo

Daily administration of placebo nasal spray plus oral placebo tablet.

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

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

Placebo tablet

Intervention Type: DRUG

Daily dose of placebo administered as an oral tablet for 15 days.

Interventions

Mometasone furoate nasal spray (MFNS)

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

Intervention Type: DRUG

Loratadine

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

Intervention Type: DRUG

Placebo nasal spray

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

Intervention Type: DRUG

Placebo tablet

Daily dose of placebo administered as an oral tablet for 15 days.

Intervention Type: DRUG

Other Intervention Names

SCH 32088; MK-0887; NASONEX®; Claritin®

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

C94-145

Identifier Type: OTHER

Identifier Source: secondary_id

C94-145

Identifier Type: -

Identifier Source: org_study_id