Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

NCT00453063 | Completed Phase 3 Results

• 1 other identifier: P05067
• Study Type: interventional
• Target: 426
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15

  TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.

  Baseline and 15 days

• Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15

  TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.

  Baseline and 15 days

Secondary Outcomes (3)

• Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15

  Baseline and 15 days

• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)

  Baseline and 15 days

• Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15

  Baseline and 15 days

Study Arms (2)

MFNS 200 mcg QD

EXPERIMENTAL

Drug: mometasone furoate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

mometasone furoate DRUG

50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning

Also known as: Nasonex, SCH 32088

MFNS 200 mcg QD

Placebo DRUG

Two sprays in each nostril once daily in the morning

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:

• Must be 12 years of age or older, of either sex and of any race.
• Must have at least a 2-year documented history of SAR which exacerbates during the study season.
• Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
• Must be clinically symptomatic at the Screening Visit.
• Must be clinically symptomatic at the Baseline Visit.
• Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count \[CBC\], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
• Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

You may not qualify if:

• A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
• A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
• Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
• A subject with rhinitis medicamentosa.
• A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
• A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
• A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
• A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Bielory L, Chun Y, Bielory BP, Canonica GW. Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: a meta-analysis. Allergy. 2011 May;66(5):686-93. doi: 10.1111/j.1398-9995.2010.02543.x. Epub 2011 Jan 25.

  PMID: 21261661 RESULT

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

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 28, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 9, 2022
• Results First Posted: May 17, 2010

Record last verified: 2022-02