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

NCT03855189 | Completed Phase 3 Results

• 1 other identifier: C93-013
• Study Type: interventional
• Target: 345
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)

  TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.

  Baseline, and Days 1 through 15 (average of 15 days of treatment)

• Number of Participants Who Experienced ≥1 Adverse Event

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.

  Up to 31 Days

• Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.

  Up to 31 Days

Secondary Outcomes (25)

• Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)

  Baseline (Day 1), Day 4

• Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)

  Baseline (Day 1), Day 8

• Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)

  Baseline (Day 1), Day 15

• Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)

  Baseline (Day 1), Day 22

• Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)

  Baseline (Day 1), Day 29

Study Arms (3)

Mometasone Furoate (MF)

EXPERIMENTAL

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.

Drug: Mometasone Furoate (MF); Drug: Placebo

Beclomethasone Dipropionate (BDP)

ACTIVE COMPARATOR

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.

Drug: Beclomethasone Dipropionate (BDP)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mometasone Furoate (MF) DRUG

Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.

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

Mometasone Furoate (MF)

Beclomethasone Dipropionate (BDP) DRUG

Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks.

Also known as: Vancenase® AQ

Beclomethasone Dipropionate (BDP)

Placebo DRUG

Placebo nasal spray administered for 4 weeks.

Mometasone Furoate (MF); Placebo

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:

• 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
• 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

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
• 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)

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate; Beclomethasone

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; Pregnadienetriols; Steroids, Chlorinated

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

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 26, 2019
• Study Start: August 23, 1993
• Primary Completion: October 8, 1993
• Study Completion: October 22, 1993
• Last Updated: February 9, 2022
• Results First Posted: August 9, 2019

Record last verified: 2022-02