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An Open-label Study to Identify Molecular Markers of Steroid Resistance (MERK2)

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ClinicalTrials.gov Identifier: NCT01616160
Recruitment Status : Terminated (Inability to recruit additional subjects.)
First Posted : June 11, 2012
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Daniel Hamilos MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Nasal Polyps
Intervention Drug: mometasone furoate
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nasal Polyps Subjects
Hide Arm/Group Description

Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID

Period Title: Overall Study
Started 11
Completed 9
Not Completed 2
Arm/Group Title Nasal Polyps Subjects
Hide Arm/Group Description

Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   9.1%
White
10
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell
Hide Description To assess steroid sensitivity in subjects comparing Trouble with sense of smell symptom scores before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Trouble with sense of smell measured on 0 to 4 scale ( 0 = no trouble with smell; 4 = severe trouble with smell). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate patients had less trouble with sense of smell at the end of the study.
Time Frame Change between pre- and post-treatment symptom score after 4 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nasal Polyps Subjects
Hide Arm/Group Description:

Intervention: Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril twice daily

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.9  (1.66)
2.Primary Outcome
Title Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores
Hide Description To assess steroid sensitivity in subjects comparing nasal endoscopy polyp score before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Nasal endoscopic polyp score measured on 0 to 4 scale ( 0 = no nasal polyp; 1 = polyp in the middle meatus, not below the inferior border of the middle turbinate (MT); 2 = polyp below the inferior border of the MT but not touching the inferior turbinate (IT); 3 = polyp below the inferior border of the MT and touching the IT; 4 = polyp to or below the lower border of the IT). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate that patients had a reduction in nasal polyp size at the end of the study.
Time Frame Change between pre- and post-treatment symptom score after 4 weeks of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.
Arm/Group Title Nasal Polyps Subjects
Hide Arm/Group Description:

Intervention: Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril twice daily

Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Right nasal polyp 0  (1.07)
Left nasal polyp -0.25  (1.66)
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Polyps Subjects
Hide Arm/Group Description

Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.

mometasone furoate: 2 sprays/nostril BID

All-Cause Mortality
Nasal Polyps Subjects
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nasal Polyps Subjects
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nasal Polyps Subjects
Affected / at Risk (%)
Total   0/11 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daniel L. Hamilos, M.D.
Organization: Massachusetts General Hospital
Phone: 617-726-5090
Responsible Party: Daniel Hamilos MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01616160     History of Changes
Other Study ID Numbers: 2012P000387
First Submitted: May 30, 2012
First Posted: June 11, 2012
Results First Submitted: March 20, 2018
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018