Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Organon

Status and phase: Completed; Phase 3

Conditions: Rhinitis, Allergic

Treatments: Drug: Loratadine; Drug: Placebo nasal spray; Drug: Placebo tablet; Drug: Mometasone furoate nasal spray (MFNS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03855228

C94-145 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

Enrollment: 704 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
• Evidence of clinically significant nasal candidiasis
• 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: Triple Blind

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704 participants in 4 patient groups, including a placebo group

MFNS 200 µg + Loratadine 10 mg

Experimental group

Description:

Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet.

Treatment:

Drug: Mometasone furoate nasal spray (MFNS)

Drug: Loratadine

MFNS 200 µg

Active Comparator group

Description:

Daily administration of 200 µg of MFNS plus oral placebo tablet.

Treatment:

Drug: Placebo tablet

Drug: Mometasone furoate nasal spray (MFNS)

Loratadine 10 mg

Active Comparator group

Description:

Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.

Treatment:

Drug: Placebo nasal spray

Drug: Loratadine

Placebo

Placebo Comparator group

Description:

Daily administration of placebo nasal spray plus oral placebo tablet.

Treatment:

Drug: Placebo tablet

Drug: Placebo nasal spray