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)

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic, Seasonal

Treatments: Drug: Placebo nasal spray; Drug: Chlorpheniramine maleate syrup; Drug: Mometasone furoate nasal spray; Drug: Beclomethasone dipropionate nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03879772

C95-161 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 679 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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679 participants in 5 patient groups, including a placebo group

MFNS 25 mcg QD

Experimental group

Description:

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.

Treatment:

Drug: Placebo nasal spray

Drug: Mometasone furoate nasal spray

Drug: Chlorpheniramine maleate syrup

MFNS 100 mcg QD

Experimental group

Description:

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.

Treatment:

Drug: Placebo nasal spray

Drug: Mometasone furoate nasal spray

Drug: Chlorpheniramine maleate syrup

MFNS 200 mcg QD

Experimental group

Description:

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.

Treatment:

Drug: Placebo nasal spray

Drug: Mometasone furoate nasal spray

Drug: Chlorpheniramine maleate syrup

BDP 84 mcg BID

Active Comparator group

Description:

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.

Treatment:

Drug: Beclomethasone dipropionate nasal spray

Drug: Chlorpheniramine maleate syrup

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo nasal spray

Drug: Chlorpheniramine maleate syrup