Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155) - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Adenoids Hypertrophy
Interventions:	Drug: Mometasone Furoate nasal spray Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
135 participants were screened, a total of 132 participants were randomized to receive either Mometasone furoate nasal spray (MFNS) (n=66) or placebo nasal spray (n=66).

Reporting Groups

	Description
Mometasone Furoate Nasal Spray	1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
Placebo Nasal Spray	1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

Participant Flow: Overall Study

	Mometasone Furoate Nasal Spray	Placebo Nasal Spray
STARTED	66	66
COMPLETED	49	47
NOT COMPLETED	17	19
Withdrawal by Subject	2	2
Protocol Violation	7	12
Lost to Follow-up	8	5

Baseline Characteristics

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Reporting Groups

	Description
Mometasone Furoate Nasal Spray	1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
Placebo Nasal Spray	1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).

Baseline Measures

	Mometasone Furoate Nasal Spray	Placebo Nasal Spray	Total
Number of Participants [units: participants]	66	66	132
Age [units: years] Mean ± Standard Deviation	5.56 ± 2.27	5.36 ± 2.50	5.46 ± 2.38
Gender [units: participants]
Female	32	23	55
Male	34	43	77

Outcome Measures

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1. Primary:

Change From Baseline in Adenoid/Choana (A/C) Index Grade [ Time Frame: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4) ]

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2. Secondary:

Total Severity Symptom Scores: Morning and Evening (AM & PM) [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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3. Secondary:

Total Frequency Symptom Scores: AM & PM [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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4. Secondary:

Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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5. Secondary:

Number of Participants With Otoscopic Results of: Normal or Abnormal [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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6. Secondary:

Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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7. Secondary:

Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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8. Secondary:

Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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9. Secondary:

Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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10. Secondary:

Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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11. Secondary:

Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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12. Secondary:

Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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13. Secondary:

Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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14. Secondary:

Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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15. Secondary:

Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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16. Secondary:

Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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17. Secondary:

Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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18. Secondary:

Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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19. Secondary:

Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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20. Secondary:

Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score [ Time Frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Principal Investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The Principal Investigator further agrees to provide thirty (30) days written notice to the SPONSOR prior to submission for publication or presentation to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the Study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The results of this study as presented are drawn from the clinical study report and should be reviewed with caution as there were inaccuracies in the database resulting from medication errors in some participants.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00552032 History of Changes
Other Study ID Numbers:	P05155
Study First Received:	October 31, 2007
Results First Received:	December 22, 2011
Last Updated:	December 22, 2011
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks