Trial Outcomes & Findings for Potential for Cortisol Suppression With the Use of High Volume Nasal Mometasone Irrigations in Varying Dosages. (NCT NCT03979209)
NCT ID: NCT03979209
Last Updated: 2024-08-12
Results Overview
The potential for cortisol suppression will be assessed with "AM" cortisol level after continuous nasal mometasone irrigation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Morning (AM) at week 12,
Results posted on
2024-08-12
Participant Flow
Recruitment from patients at Rush UMC who met the criteria for the study from 1/14/2019 to 11/11/2019.
Participant milestones
| Measure |
Mometasone 1mg
1mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
Mometasone 2mg
2mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
Mometasone 4mg
4mg capsule dissolved in 240mg saline solution nasal irrigation. Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
14
|
0
|
|
Overall Study
COMPLETED
|
2
|
14
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potential for Cortisol Suppression With the Use of High Volume Nasal Mometasone Irrigations in Varying Dosages.
Baseline characteristics by cohort
| Measure |
Mometasone 1mg
n=2 Participants
1mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
Mometasone 2mg
n=14 Participants
2mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Diagnosis of Chronic Rhinosinusitis, with or without nasal polyposis
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
History of prior endosopic sinus surgery o Must include at least ethmoidectomy with maxillary antros
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Morning (AM) at week 12,Population: The morning "AM" cortisol levels were added for each participant in the arms.
The potential for cortisol suppression will be assessed with "AM" cortisol level after continuous nasal mometasone irrigation.
Outcome measures
| Measure |
Mometasone 1mg
n=2 Participants
1mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
Mometasone 2mg
n=14 Participants
2mg capsule dissolved in 240mg saline solution nasal irrigation
Nasal Mometasone Rinse: Nasal irrigation twice a day (BID) of assigned dose.
|
|---|---|---|
|
Morning "AM" Serum Cortisol Level
|
17.35 mcg/dL
Interval 13.1 to 21.6
|
14.48 mcg/dL
Interval 9.3 to 24.8
|
Adverse Events
Mometasone 1mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mometasone 2mg
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place