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Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00733005
First received: August 8, 2008
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  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:

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The 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 ]

Secondary Outcome Measures:
  • The 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 ]

Enrollment: 324
Study Start Date: July 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00733005     History of Changes
Other Study ID Numbers: P05528
Study First Received: August 8, 2008
Results First Received: October 13, 2009
Last Updated: February 3, 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
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013