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

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Fluticasone propionate placebo; Drug: Fluticasone propionate; Drug: Mometasone furoate placebo; Drug: Mometasone furoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03882047

I94-001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 313 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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313 participants in 3 patient groups, including a placebo group

Mometasone furoate nasal spray

Experimental group

Description:

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

Treatment:

Drug: Mometasone furoate

Drug: Fluticasone propionate placebo

Fluticasone propionate nasal spray

Active Comparator group

Description:

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

Treatment:

Drug: Fluticasone propionate

Drug: Mometasone furoate placebo

Placebo nasal spray

Placebo Comparator group

Description:

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

Treatment:

Drug: Mometasone furoate placebo

Drug: Fluticasone propionate placebo