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Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

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ClinicalTrials.gov Identifier: NCT00728416
Recruitment Status : Completed
First Posted : August 5, 2008
Results First Posted : November 19, 2009
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Mometasone furoate nasal spray (MFNS) Drug: Matching placebo nasal spray Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Study Start Date : August 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Mometasone furoate nasal spray 200 mcg QD (once per day)
Drug: Mometasone furoate nasal spray (MFNS)
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Other Name: MK-0887, Nasonex Nasal Spray
Placebo Comparator: Arm 2
Matching placebo nasal spray
Drug: Matching placebo nasal spray
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Other Name: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days [ Time Frame: 15 days of treatment ]
    Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.


Secondary Outcome Measures :
  1. Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days [ Time Frame: 15 days of treatment ]
    Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A subject must be 12 years of age or older, of either sex, and of any race.
  • A subject must have at least a 2-year history of SAR which exacerbates during the study season.
  • A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
  • A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

  • A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
  • A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
  • A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
  • A subject who is participating in any other clinical study.
  • A subject who is part of the staff personnel directly involved with this study.
  • A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
  • A female subject who is breast-feeding, pregnant, or intends to become pregnant.
  • A subject previously randomized into this study.
  • A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728416


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00728416     History of Changes
Other Study ID Numbers: P05583
MK-0887-160 ( Other Identifier: Merck )
First Posted: August 5, 2008    Key Record Dates
Results First Posted: November 19, 2009
Last Update Posted: September 16, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents