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

February 7, 2022 updated by: Organon and Co

Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

707

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination1
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)
MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).
Other Names:
  • MFNS + OXY combination
Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.
Other Names:
  • MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1
Experimental: Combination3
MFNS with OXY 3 sprays once daily
Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).
Other Names:
  • MFNS + OXY combination
Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.
Other Names:
  • MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1
Active Comparator: Mometasone
MFNS once daily
Drug: mometasone furoate nasal spray (MFNS) once daily
MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.
Other Names:
  • MFNS QD
Active Comparator: Oxymetazoline
OXY twice daily
Drug: oxymetazoline nasal spray (OXY) twice daily
OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.
Other Names:
  • OXY BID
Placebo Comparator: Placebo
Placebo nasal spray
Drug: Placebo
Matching placebo to MFNS given every morning and every evening x 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15
Time Frame: 15 days of treatment
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
Time Frame: from baseline to hour 4 on Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Ariel A Teper, MD, Schering-Plough

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 1, 2007

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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