Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

NCT ID: NCT03879772

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 679 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-12
• Study Completion Date: 1996-07-01

Brief Summary

The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Conditions

Rhinitis, Allergic, Seasonal

Study Design

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

Study Groups

MFNS 25 mcg QD

Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Group Type: EXPERIMENTAL

Mometasone furoate nasal spray

Intervention Type: DRUG

intranasal administration

Placebo nasal spray

Intervention Type: DRUG

intranasal administration

Chlorpheniramine maleate syrup

Intervention Type: DRUG

oral administration

MFNS 100 mcg QD

Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Group Type: EXPERIMENTAL

Mometasone furoate nasal spray

Intervention Type: DRUG

intranasal administration

Placebo nasal spray

Intervention Type: DRUG

intranasal administration

Chlorpheniramine maleate syrup

Intervention Type: DRUG

oral administration

MFNS 200 mcg QD

Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Group Type: EXPERIMENTAL

Mometasone furoate nasal spray

Intervention Type: DRUG

intranasal administration

Placebo nasal spray

Intervention Type: DRUG

intranasal administration

Chlorpheniramine maleate syrup

Intervention Type: DRUG

oral administration

BDP 84 mcg BID

Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Group Type: ACTIVE_COMPARATOR

Beclomethasone dipropionate nasal spray

Intervention Type: DRUG

intranasal administration

Chlorpheniramine maleate syrup

Intervention Type: DRUG

oral administration

Placebo

Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

intranasal administration

Chlorpheniramine maleate syrup

Intervention Type: DRUG

oral administration

Interventions

Mometasone furoate nasal spray

intranasal administration

Intervention Type: DRUG

Beclomethasone dipropionate nasal spray

intranasal administration

Intervention Type: DRUG

Placebo nasal spray

intranasal administration

Intervention Type: DRUG

Chlorpheniramine maleate syrup

oral administration

Intervention Type: DRUG

Other Intervention Names

Nasonex®; MK-0887; SCH 032088; Vancenase®; ChlorTrimeton Syrup

Eligibility Criteria

Inclusion Criteria

• Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen
• Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year.
• Must be free of any clinically significant disease other than seasonal allergic rhinitis.
• Must be pre-menarcheal.

Exclusion Criteria

• History of asthma which requires chronic use of inhaled or systemic corticosteroids.
• Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
• History of rhinitis medicamentosa.
• History of clinically significant nasal candidiasis.
• History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines.
• History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening.
• History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow.
• History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines.
• History of investigational drug use in the last 30 days.
• History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 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

C95-161

Identifier Type: OTHER

Identifier Source: secondary_id

C95-161

Identifier Type: -

Identifier Source: org_study_id