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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00728416
First received: July 31, 2008
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days [ Time Frame: 15 days of treatment ] [ Designated as safety issue: No ]
    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])


Secondary Outcome Measures:
  • Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days [ Time Frame: 15 days of treatment ] [ Designated as safety issue: No ]
    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])


Enrollment: 333
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00728416     History of Changes
Other Study ID Numbers: P05583
Study First Received: July 31, 2008
Results First Received: October 9, 2009
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 19, 2014