Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Mometasone Furoate (MF); Drug: Placebo; Drug: Beclomethasone Dipropionate (BDP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03855189

C93-013 (Other Identifier)

Details and patient eligibility

About

The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.

Enrollment: 345 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to Screening, and must continue its use for the duration of the study. Women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children
• 2-year history of seasonal allergic rhinitis
• Positive skin test response to a local seasonal allergen within last 2 years
• 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
• Pre-menarchal females
• Asthma requiring therapy with inhaled or systemic corticosteroids
• Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study
• On immunotherapy (unless maintenance therapy)
• Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks
• Use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days
• Large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow
• Allergy to corticosteroids, or a history of multiple drug allergies
• History of posterior subcapsular cataracts
• Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa
• Chronic use of any medication which could affect the course of seasonal allergic rhinitis
• Clinically significant abnormal electrocardiogram (ECG)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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345 participants in 3 patient groups, including a placebo group

Mometasone Furoate (MF)

Experimental group

Description:

Participants receive 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.

Treatment:

Drug: Mometasone Furoate (MF)

Drug: Placebo

Beclomethasone Dipropionate (BDP)

Active Comparator group

Description:

Participants receive 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.

Treatment:

Drug: Beclomethasone Dipropionate (BDP)

Placebo

Placebo Comparator group

Description:

Participants receive nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.

Treatment:

Drug: Placebo