Study Stopped
Recruitment failure.
Itraconazole for Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
Randomized Double-Blinded Controlled Trial of Oral Antifungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis With Nasal Polyps
1 other identifier
interventional
58
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 4, 2014
CompletedFirst Posted
Study publicly available on registry
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedResults Posted
Study results publicly available
October 28, 2020
CompletedOctober 28, 2020
October 1, 2020
4.5 years
November 4, 2014
October 8, 2020
October 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Recurrence of Nasal Polyps Requiring Intervention
Recurrence of nasal polyps requiring intervention
48 weeks
Secondary Outcomes (1)
Number of Participants With Adverse Events During Time Frame of Taking Medication/Placebo
24 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATOR2 capsules by mouth twice a day for 24 weeks
Itraconazole
ACTIVE COMPARATORTwo 100mg capsules by mouth twice a day for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Medical School at Houston
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed
Results Point of Contact
- Title
- Amber U. Luong, MD, PhD
- Organization
- The University of Texas Health Science Center at Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Amber Luong, MD, PhD
The University of Texas Health Science Center, Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
November 4, 2014
First Posted
November 6, 2014
Study Start
November 1, 2014
Primary Completion
May 15, 2019
Study Completion
May 15, 2019
Last Updated
October 28, 2020
Results First Posted
October 28, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share