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A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01165424
First received: May 28, 2010
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  Purpose

Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.


Condition Intervention Phase
Rhinitis, Allergic, Perennial
 Drug: mometasone furoate
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of Participants With Adverse Events and Adverse Drug Reactions [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in the Total Nasal Symptom Score [ Time Frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) ] [ Designated as safety issue: No ]
    Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.


Enrollment: 80
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MFNS 50 μg device

MFNS 50 μg spray device. The dose will be as follows:

  • 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
  • 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
 Drug: mometasone furoate

MFNS 50 μg spray device

  • 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
  • 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Other Name: Nasonex

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
  • Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
  • Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion Criteria:

  • Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
  • Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
  • Subjects with repeated epistaxis
  • Subjects with coexisting fungal infection in nasal/sinus cavity
  • Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
  • Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
  • Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough
ClinicalTrials.gov Identifier: NCT01165424     History of Changes
Other Study ID Numbers: P06333
Study First Received: May 28, 2010
Results First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013