Trial Outcomes & Findings for An Open-label Study to Identify Molecular Markers of Steroid Resistance (NCT NCT01616160)

NCT ID: NCT01616160

Last Updated: 2018-06-12

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: Change between pre- and post-treatment symptom score after 4 weeks of treatment
• Results posted on: 2018-06-12

Participant Flow

Participant milestones

Measure	Nasal Polyps Subjects Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks. mometasone furoate: 2 sprays/nostril BID
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nasal Polyps Subjects n=11 Participants Intervention: Each subject will receive Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks. mometasone furoate: 2 sprays/nostril BID
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Change between pre- and post-treatment symptom score after 4 weeks of treatment

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.

Outcome measures

Measure	Nasal Polyps Subjects n=9 Participants Intervention: Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks. mometasone furoate: 2 sprays/nostril twice daily
Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell	-0.9 scores on a scale Standard Deviation 1.66

PRIMARY outcome

Timeframe: Change between pre- and post-treatment symptom score after 4 weeks of treatment

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

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.

Outcome measures

Measure	Nasal Polyps Subjects n=9 Participants Intervention: Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks. mometasone furoate: 2 sprays/nostril twice daily
Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores Right nasal polyp	0 units on a scale Standard Deviation 1.07
Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores Left nasal polyp	-0.25 units on a scale Standard Deviation 1.66

Adverse Events

Nasal Polyps Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel L. Hamilos, M.D.

Massachusetts General Hospital

Phone: 617-726-5090

Email: dhamilos@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place