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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00552032
First received: October 31, 2007
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: December 22, 2011  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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).
Total Total of all reporting groups

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) ]

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

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

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) ]

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) ]

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) ]

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) ]

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) ]

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

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

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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: Merck Sharp & Dohme Corp.
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: April 29, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks