Chronic Rhinosinusitis
Conditions
Brief summary
The purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Detailed description
CRSwNP patients scheduled for medically-indicated sinus surgery will undergo screening ELIspot assay to identify patients with fungal sensitivity based on positive fungal induced interleukin 4 (IL-4) ELIspot. Enrolled fungal sensitive CRSwNP patients will undergo their sinus surgery and randomized into either placebo or itraconazole 200 mg taken by mouth twice a day (PO BID) for 24 weeks in addition to standardized post-surgical regimen (9 days of perioperative prednisone, saline irrigations and pain medication as needed). Patients will be followed as outpatient in rhinology clinic for 48 weeks total. During these post-op visits, compliance with medications will be determined. Patients will be questioned about any possible side effects or adverse events to post-operative medications. Then, the patients will be evaluated by 2 nasal specific quality of life questionnaires and nasal endoscopy. The goals of the nasal endoscopy are to evaluate the state of the sinus mucosa and to determine recurrence of nasal polyps.
Interventions
DRUGItraconazole
DRUGPlacebo
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery
Exclusion criteria
* cystic fibrosis * aspirin exacerbated respiratory disease * uncontrolled or unstable chronic diseases such as uncontrolled diabetes * active or history of cancer * HIV positive * history of liver or kidney disease * history of disease with effects on immune system * pregnant * allergy to triazole antifungals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Nasal Polyps Requiring Intervention | 48 weeks | Recurrence of nasal polyps requiring intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo | 24 weeks | Adverse events during time frame of taking medication/placebo |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo 2 capsules by mouth twice a day for 24 weeks
Placebo | 29 |
| Itraconazole Two 100mg capsules by mouth twice a day for 24 weeks
Itraconazole | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Placebo | Itraconazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 26 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 25 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 22 Participants | 17 Participants | 39 Participants |
| Region of Enrollment United States | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 19 Participants | 18 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention
Recurrence of nasal polyps requiring intervention
Time frame: 48 weeks
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Recurrence of Nasal Polyps Requiring Intervention | 3 Participants |
| Itraconazole | Number of Participants With Recurrence of Nasal Polyps Requiring Intervention | 4 Participants |
Secondary
Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo
Adverse events during time frame of taking medication/placebo
Time frame: 24 weeks
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo | 0 Participants |
| Itraconazole | Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo | 0 Participants |