Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

NCT03882047 | Completed Phase 3 Results

• 1 other identifier: I94-001
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)

  Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.

  Baseline and Day 1 through Day 15 (averaged over 15 days)

Secondary Outcomes (10)

• Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)

  Baseline (Day 1) and Day 4

• Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)

  Baseline (Day 1) and Day 15

• Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)

  Baseline (Day 1) and Day 4

• Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)

  Baseline (Day 1) and Day 15

• Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)

  Baseline (Day 1) and Day 4

Study Arms (3)

Mometasone furoate nasal spray

EXPERIMENTAL

Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily.

Drug: Mometasone furoate; Drug: Fluticasone propionate placebo

Fluticasone propionate nasal spray

ACTIVE COMPARATOR

Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily.

Drug: Fluticasone propionate; Drug: Mometasone furoate placebo

Placebo nasal spray

PLACEBO COMPARATOR

Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.

Drug: Mometasone furoate placebo; Drug: Fluticasone propionate placebo

Interventions

Mometasone furoate DRUG

Mometasone furoate nasal spray, 200 mg once daily

Also known as: NASONEX®, MK-0887, SCH 032088

Mometasone furoate nasal spray

Fluticasone propionate DRUG

Fluticasone propionate nasal spray, 200 mg once daily

Also known as: FLONASE®

Fluticasone propionate nasal spray

Mometasone furoate placebo DRUG

Mometasone furoate placebo matching nasal spray, once daily

Fluticasone propionate nasal spray; Placebo nasal spray

Fluticasone propionate placebo DRUG

Fluticasone propionate placebo matching nasal spray, once daily

Mometasone furoate nasal spray; Placebo nasal spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes

Limitations and Caveats

AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigator were blinded to treatment identity. Because the mometasone furoate and fluticasone propionate bottles were not identical in appearance, a double-dummy study design was used and each bottle had a matching placebo. Thus, although participants received bottles of different appearance, they did not know whether bottles contained active substance or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: August 11, 1994
• Primary Completion: September 16, 1994
• Study Completion: September 16, 1994
• Last Updated: February 9, 2022
• Results First Posted: September 6, 2019

Record last verified: 2022-02