Clinical Trial Results:
Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
Summary
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EudraCT number |
2014-004923-40 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
30 Sep 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Apr 2016
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First version publication date |
19 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
P04367 - Lebanon
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01098071 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Merck Registration Number: MK-0887-096 | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Sep 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Sep 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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).
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Lebanon: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
2
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Children (2-11 years) |
32
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
34 participants enrolled in the study, 19 completed treatment and follow-up, and 15 patients discontinued the study. | ||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Mometasone furoate nasal spray | ||||||||||||
Arm description |
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Mometasone Furoate nasal spray
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Investigational medicinal product code |
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Other name |
Nasonex®, MK-0887, SCH 032088
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months. After initial priming, each actuation of the pump delivers a metered spray containing 100 mcg of suspension (50 mcg mometasone furoate monohydrate).
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Baseline characteristics reporting groups
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Reporting group title |
Mometasone furoate nasal spray
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Reporting group description |
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mometasone furoate nasal spray
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Reporting group description |
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months |
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End point title |
Severity of nasal obstruction symptoms at Baseline and Week 12 as measured by the total clinical score [1] | ||||||||||||
End point 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]). Only participants who completed the study were included in this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline and Week 12 (Visit 2)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No between-group statistical analyses were performed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Degree of posterior choana obstruction at Baseline and Week 12 [2] | ||||||||||||
End point 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.
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End point type |
Primary
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End point timeframe |
Baseline and Week 12 (Visit 2)
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No between-group statistical analyses were performed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of participants referred to surgery (adenoidectomy) within 12 weeks of start of therapy [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline to 12 weeks (Visit 2)
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No between-group statistical analyses were performed for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Severity of rhinorrhea at Baseline and Week 12 | ||||||||||||
End point 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]) in participants with suspected allergic rhinitis at baseline.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12 (Visit 2)
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No statistical analyses for this end point |
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End point title |
Severity of nasal congestion at Baseline and Week 12 | ||||||||||||
End point 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]) in participants with suspected allergic rhinitis at baseline.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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No statistical analyses for this end point |
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End point title |
Severity of nasal itching at Baseline and Week 12 | ||||||||||||
End point 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]) in participants with suspected allergic rhinitis at baseline.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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No statistical analyses for this end point |
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End point title |
Severity of sneezing at Baseline and Week 12 | ||||||||||||
End point 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]) in participants with suspected allergic rhinitis at baseline.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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No statistical analyses for this end point |
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End point title |
Severity of eye symptoms at Baseline and Week 12 | ||||||||||||
End point 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]) in participants with suspected allergic rhinitis at baseline.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 12
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From Screening visit up to 30 days after completion or discontinuation from study (up to 15 months)
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Adverse event reporting additional description |
In this study, symptoms of allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing, and eye symptoms) were not reported as adverse events.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
Mometasone furoate nasal spray
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Reporting group description |
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No AEs were reported during the course of the study. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |