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

Sponsor:	Schering-Plough
Collaborator:	Quintiles
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00552110

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) Drug: mometasone furoate nasal spray (MFNS) once daily Drug: oxymetazoline nasal spray (OXY) twice daily Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Mometasone furoate Oxymetazoline Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	707
Study Start Date:	July 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: MFNS + OXY combination
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 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening. Other Name: 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 Name: 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 Name: OXY BID
Placebo Comparator: Placebo Placebo nasal spray	Drug: Placebo Matching placebo to MFNS given every morning and every evening x 2 weeks. Other Name: Placebo

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552110

Sponsors and Collaborators

Schering-Plough

Quintiles

Investigators

Study Director:

Ariel A Teper, MD

Schering-Plough

More Information

No publications provided

Responsible Party:	Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00552110 History of Changes
Other Study ID Numbers:	P04500
Study First Received:	October 30, 2007
Results First Received:	May 15, 2009
Last Updated:	October 22, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Oxymetazoline
Phenylephrine
Mometasone furoate
Adrenergic alpha-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents

ClinicalTrials.gov processed this record on February 09, 2012