Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: mometasone furoate nasal spray; Drug: placebo nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03861559

C93-184 (Other Identifier)

Details and patient eligibility

About

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

Enrollment: 201 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a 2-year history of seasonal allergic rhinitis
• Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
• Is in 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
• Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
• Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
• Is on immunotherapy with the exception of maintenance therapy
• Has a clinically significant upper respiratory or sinus infection
• Has used an investigational drug within the previous 30 days
• Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
• Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
• Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
• Has rhinitis medicamentosa
• Is using of any chronic medication which could affect the course of seasonal allergic rhinitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups, including a placebo group

mometasone furoate nasal spray

Experimental group

Description:

Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days.

Treatment:

Drug: mometasone furoate nasal spray

placebo nasal spray

Placebo Comparator group

Description:

Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.

Treatment:

Drug: placebo nasal spray