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

Primary Purpose

Adenoids

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
mometasone furoate nasal spray
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoids

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    mometasone furoate nasal spray

    Arm Description

    Outcomes

    Primary Outcome Measures

    Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
    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
    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

    Secondary Outcome Measures

    Severity of Rhinorrhea at 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
    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
    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
    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
    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]).

    Full Information

    First Posted
    April 1, 2010
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01098071
    Brief Title
    Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
    Acronym
    NAHCh
    Official Title
    Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2008 (Actual)
    Primary Completion Date
    September 1, 2009 (Actual)
    Study Completion Date
    September 1, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenoids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    mometasone furoate nasal spray
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    mometasone furoate nasal spray
    Other Intervention Name(s)
    SCH 32088, Nasonex
    Intervention Description
    One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
    Primary Outcome Measure Information:
    Title
    Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
    Description
    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]).
    Time Frame
    Baseline and Week 12
    Title
    Degree of Posterior Choana Obstruction at Baseline and Week 12
    Description
    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.
    Time Frame
    Baseline and Week 12
    Title
    Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
    Time Frame
    Baseline to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Severity of Rhinorrhea at Baseline and Week 12
    Description
    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]).
    Time Frame
    Baseline and Week 12
    Title
    Severity of Nasal Congestion at Baseline and Week 12
    Description
    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]).
    Time Frame
    Baseline and Week 12
    Title
    Severity of Nasal Itching at Baseline and Week 12
    Description
    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]).
    Time Frame
    Baseline and Week 12
    Title
    Severity of Sneezing at Baseline and Week 12
    Description
    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]).
    Time Frame
    Baseline and Week 12
    Title
    Severity of Eye Symptoms at Baseline and Week 12
    Description
    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]).
    Time Frame
    Baseline and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    23010795
    Citation
    Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. Epub 2012 Aug 22.
    Results Reference
    result

    Learn more about this trial

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

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