Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

NCT03861559 | Completed Phase 3 Results

• 1 other identifier: C93-184
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

• Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses

  Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.

  From the start of treatment until onset of symptom relief (up to Day 4)

Secondary Outcomes (16)

• Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant

  Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)

• Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator

  Baseline (Day 1) and Day 4

• Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator

  Baseline (Day 1) and Day 8

• Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator

  Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

• Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator

  Baseline (Day 1) and Day 4

Other Outcomes (4)

• Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant

  Baseline (3 days preceding treatment)

• Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator

  Baseline (Day 1)

• Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator

  Baseline (Day 1)

Study Arms (2)

mometasone furoate nasal spray

EXPERIMENTAL

Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days.

Drug: mometasone furoate nasal spray

placebo nasal spray

PLACEBO COMPARATOR

Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.

Drug: placebo nasal spray

Interventions

mometasone furoate nasal spray DRUG

intranasal administration

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

mometasone furoate nasal spray

placebo nasal spray DRUG

intranasal administration

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:

• Has a 2-year history of seasonal allergic rhinitis
• Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
• Is in 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
• Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
• Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
• Is on immunotherapy with the exception of maintenance therapy
• Has a clinically significant upper respiratory or sinus infection
• Has used an investigational drug within the previous 30 days
• Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
• Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
• Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
• Has rhinitis medicamentosa
• Is using of any chronic medication which could affect the course of seasonal allergic rhinitis

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate

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

Limitations and Caveats

Adverse Event 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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: March 30, 1994
• Primary Completion: June 27, 1994
• Study Completion: July 7, 1994
• Last Updated: February 9, 2022
• Results First Posted: September 20, 2019

Record last verified: 2022-02