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

NCT03855228 | Completed Phase 3 Results

• 1 other identifier: C94-145
• Study Type: interventional
• Target: 704
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)

  Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

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

• Change From Baseline in Total Symptom Score (Assessed by Participant)

  Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

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

Secondary Outcomes (8)

• Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)

  Baseline and study day 15

• Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)

  Baseline and study day 15

• Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)

  Baseline and study day 8

• Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)

  Baseline and study day 8

• Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)

  Baseline and study day 15

Study Arms (4)

MFNS 200 µg + Loratadine 10 mg

EXPERIMENTAL

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

Drug: Mometasone furoate nasal spray (MFNS); Drug: Loratadine

MFNS 200 µg

ACTIVE COMPARATOR

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

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

Loratadine 10 mg

ACTIVE COMPARATOR

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

Drug: Loratadine; Drug: Placebo nasal spray

Placebo

PLACEBO COMPARATOR

Daily administration of placebo nasal spray plus oral placebo tablet.

Drug: Placebo nasal spray; Drug: Placebo tablet

Interventions

Mometasone furoate nasal spray (MFNS) DRUG

Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.

Also known as: SCH 32088, MK-0887, NASONEX®

MFNS 200 µg; MFNS 200 µg + Loratadine 10 mg

Loratadine DRUG

Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.

Also known as: Claritin®

Loratadine 10 mg; MFNS 200 µg + Loratadine 10 mg

Placebo nasal spray DRUG

Daily dose of placebo administered as a nasal spray for 15 days.

Loratadine 10 mg; Placebo

Placebo tablet DRUG

Daily dose of placebo administered as an oral tablet for 15 days.

MFNS 200 µg; 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:

• 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
• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate; Loratadine

Condition Hierarchy (Ancestors)

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; Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: March 1, 1995
• Primary Completion: August 7, 1995
• Study Completion: August 7, 1995
• Last Updated: February 9, 2022
• Results First Posted: July 26, 2019

Record last verified: 2022-02