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
About this trial
This is an interventional treatment trial for Adenoids
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.
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
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
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Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
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