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

NCT ID: NCT00552110

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-02-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combination1

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

Combination3

MFNS with OXY 3 sprays once daily

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.

Mometasone

MFNS once daily

Group Type: ACTIVE_COMPARATOR

mometasone furoate nasal spray (MFNS) once daily

Intervention Type: DRUG

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

Oxymetazoline

OXY twice daily

Group Type: ACTIVE_COMPARATOR

oxymetazoline nasal spray (OXY) twice daily

Intervention Type: DRUG

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

Placebo

Placebo nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

oxymetazoline nasal spray (OXY) twice daily

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

MFNS + OXY combination; MFNS + OXY combination assessing a different dose (ie, number of sprays) from that used in Group 1; MFNS QD; OXY BID

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariel A Teper, MD

Role: STUDY_DIRECTOR

Schering-Plough

References

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.

Reference Type: RESULT

PMID: 23562197 (View on PubMed)

Other Identifiers

P04500

Identifier Type: -

Identifier Source: org_study_id