Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

NCT00552110 | Completed Phase 2 Results

• 1 other identifier: P04500
• Study Type: interventional
• Target: 707
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15

  Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.

  15 days of treatment

• Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score

  Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.

  from baseline to hour 4 on Day 1

Study Arms (5)

Combination1

EXPERIMENTAL

Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily

Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)

Combination3

EXPERIMENTAL

MFNS with OXY 3 sprays once daily

Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)

Mometasone

ACTIVE COMPARATOR

MFNS once daily

Drug: mometasone furoate nasal spray (MFNS) once daily

Oxymetazoline

ACTIVE COMPARATOR

OXY twice daily

Drug: oxymetazoline nasal spray (OXY) twice daily

Placebo

PLACEBO COMPARATOR

Placebo nasal spray

Drug: Placebo

Interventions

OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) DRUG

MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).

Also known as: MFNS + OXY combination

Combination1

mometasone furoate nasal spray (MFNS) once daily DRUG

MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.

Also known as: MFNS QD

Mometasone

oxymetazoline nasal spray (OXY) twice daily DRUG

OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.

Also known as: OXY BID

Oxymetazoline

Placebo DRUG

Matching placebo to MFNS given every morning and every evening x 2 weeks.

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 time period over which the subject will be participating.
• Must have a documented (within the past 12 months) positive skin-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating.
• Must be clinically symptomatic at the Screening and Baseline Visits.
• Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram results.
• Must be free of any clinically significant disease, other than SAR, which would interfere with the study evaluations.
• Must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and study requirements.
• Female subjects of child-bearing potential must have a negative serum pregnancy test at screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control prior to screening and during the entire study.
• Must have the ability to transmit electronic diary data on a regular basis.

You may not qualify if:

• A subject with 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.
• A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
• A subject with rhinitis medicamentosa.
• A subject with glaucoma and/or increased intraocular pressure.
• 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.
• A pregnant or nursing female.
• A subject with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, pulmonary, autoimmune disease, or other disease that precludes the subject's participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.

Sponsors & Collaborators

• Organon and Co: lead
• Quintiles, Inc.: collaborator

Related Publications (1)

• Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.

  PMID: 23562197 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

Study Officials

• Ariel A Teper, MD

  Schering-Plough

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: November 1, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 14, 2024
• Results First Posted: July 8, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share