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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165424
First Posted: July 19, 2010
Last Update Posted: April 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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

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

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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01165424     History of Changes
Other Study ID Numbers: P06333
First Submitted: May 28, 2010
First Posted: July 19, 2010
Results First Submitted: December 16, 2011
Results First Posted: January 23, 2012
Last Update Posted: April 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
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