Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

NCT ID: NCT03882047

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-08-11
• Study Completion Date: 1994-09-16

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

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

Study Groups

Mometasone furoate nasal spray

Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.

Group Type: EXPERIMENTAL

Mometasone furoate

Intervention Type: DRUG

Mometasone furoate nasal spray, 200 mg once daily

Fluticasone propionate placebo

Intervention Type: DRUG

Fluticasone propionate placebo matching nasal spray, once daily

Fluticasone propionate nasal spray

Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.

Group Type: ACTIVE_COMPARATOR

Fluticasone propionate

Intervention Type: DRUG

Fluticasone propionate nasal spray, 200 mg once daily

Mometasone furoate placebo

Intervention Type: DRUG

Mometasone furoate placebo matching nasal spray, once daily

Placebo nasal spray

Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.

Group Type: PLACEBO_COMPARATOR

Mometasone furoate placebo

Intervention Type: DRUG

Mometasone furoate placebo matching nasal spray, once daily

Fluticasone propionate placebo

Intervention Type: DRUG

Fluticasone propionate placebo matching nasal spray, once daily

Interventions

Mometasone furoate

Mometasone furoate nasal spray, 200 mg once daily

Intervention Type: DRUG

Fluticasone propionate

Fluticasone propionate nasal spray, 200 mg once daily

Intervention Type: DRUG

Mometasone furoate placebo

Mometasone furoate placebo matching nasal spray, once daily

Intervention Type: DRUG

Fluticasone propionate placebo

Fluticasone propionate placebo matching nasal spray, once daily

Intervention Type: DRUG

Other Intervention Names

NASONEX®; MK-0887; SCH 032088; FLONASE®

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
• 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

I94-001

Identifier Type: OTHER

Identifier Source: secondary_id

I94-001

Identifier Type: -

Identifier Source: org_study_id