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”

The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray and oxymetazoline nasal spray given together once a day in treating subjects with seasonal allergic rhinitis 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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
  • MFNS with OXY once daily x 2 weeks. Matching placebo to MFNS given every evening.
• Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)
  • MFNS with OXY once daily x 2 weeks. Matching placebo to MFNS given every evening.
• Drug: mometasone furoate nasal spray (MFNS) once daily
  • MFNS once daily x 2 weeks. Matching placebo to MFNS given every morning and every evening.
• Drug: oxymetazoline nasal spray (OXY) twice daily
  • OXY twice daily. Matching placebo to MFNS given every morning.
• Drug: Placebo
  • Matching placebo to MFNS given every morning and every evening.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
  • Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) once daily
• Experimental: Group 2
  • MFNS with OXY once daily (Group 2 assessed a different dose [ie, number of sprays] from that used in Group 1)
• Active Comparator: Group 3
  • MFNS once daily
• Active Comparator: Group 4
  • OXY twice daily
• Placebo Comparator: Group 5
  • Placebo nasal spray

Primary 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
    Safety Issue?: No
• Standardized AUC(0-4 hr) of the change from baseline in nasal congestion score on Day 1
  • Time Frame: 15 days of treatment
    Safety Issue?: No

Secondary Measures

• Change from baseline in AM/PM NOW TNSS for each of Days 1, 2, 3, 4, 1 to 8, 9 to 15, and 16 to 22
  • Time Frame: 15 days of treatment followed by 7-day post-treatment follow-up period
    Safety Issue?: No
• Change from baseline in AM, PM, and AM/PM peak nasal inspiratory flow (PNIF) for each of Days 1, 2, 3, 4, 1 to 8, 9 to 15, 16 to 22, and 1 to 15
  • Time Frame: 15 days of treatment followed by 7-day post-treatment follow-up period
    Safety Issue?: No
• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) total score at Day 15 and endpoint
  • Time Frame: 15 days of treatment followed by 7-day post-treatment follow-up period
    Safety Issue?: No
• Safety: AEs, vital signs, ECGs, and laboratory tests summarized by treatment group
  • Time Frame: 15 days of treatment followed by 7-day post-treatment follow-up period
    Safety Issue?: Yes

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 ECG 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 require 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Ariel A Teper, MD Study Director Schering-Plough  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00552110

Study ID Number: P04500

ClinicalTrials.gov Identifier: NCT00552110

Health Authority: United States: Food and Drug Administration