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Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367) (NAHCh)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01098071
First Posted: April 2, 2010
Last Update Posted: October 17, 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
To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).

Condition Intervention Phase
Adenoids Drug: mometasone furoate nasal spray Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score [ Time Frame: Baseline and Week 12 ]
    Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).

  • Degree of Posterior Choana Obstruction at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.

  • Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy [ Time Frame: Baseline to 12 weeks ]

Secondary Outcome Measures:
  • Severity of Rhinorrhea at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  • Severity of Nasal Congestion at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  • Severity of Nasal Itching at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  • Severity of Sneezing at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

  • Severity of Eye Symptoms at Baseline and Week 12 [ Time Frame: Baseline and Week 12 ]
    Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).


Enrollment: 34
Actual Study Start Date: August 1, 2008
Study Completion Date: September 1, 2009
Primary Completion Date: September 1, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mometasone furoate nasal spray Drug: mometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Other Names:
  • SCH 32088
  • Nasonex

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion Criteria:

  • adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01098071     History of Changes
Other Study ID Numbers: P04367 - Lebanon
First Submitted: April 1, 2010
First Posted: April 2, 2010
Results First Submitted: June 13, 2011
Results First Posted: November 29, 2011
Last Update Posted: October 17, 2017
Last Verified: September 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

URL: http://

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents