Trial Outcomes & Findings for Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps (NCT NCT02285283)
NCT ID: NCT02285283
Last Updated: 2020-10-28
Results Overview
Recurrence of nasal polyps requiring intervention
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
58 participants
Primary outcome timeframe
48 weeks
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Placebo
2 capsules by mouth twice a day for 24 weeks
Placebo
|
Itraconazole
Two 100mg capsules by mouth twice a day for 24 weeks
Itraconazole
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
25
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
2 capsules by mouth twice a day for 24 weeks
Placebo
|
Itraconazole
n=29 Participants
Two 100mg capsules by mouth twice a day for 24 weeks
Itraconazole
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: 33 participants were lost to follow up, and data was not collected for these 33 participants (16 in the placebo arm and 17 in the itraconazole arm).
Recurrence of nasal polyps requiring intervention
Outcome measures
| Measure |
Placebo
n=13 Participants
2 capsules by mouth twice a day for 24 weeks
Placebo
|
Itraconazole
n=12 Participants
Two 100mg capsules by mouth twice a day for 24 weeks
Itraconazole
|
|---|---|---|
|
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 33 participants were lost to follow up, and data was not collected for these 33 participants (16 in the placebo arm and 17 in the itraconazole arm).
Adverse events during time frame of taking medication/placebo
Outcome measures
| Measure |
Placebo
n=13 Participants
2 capsules by mouth twice a day for 24 weeks
Placebo
|
Itraconazole
n=12 Participants
Two 100mg capsules by mouth twice a day for 24 weeks
Itraconazole
|
|---|---|---|
|
Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Itraconazole
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
Amber U. Luong, MD, PhD
The University of Texas Health Science Center at Houston
Phone: 713-486-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place