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CFTR Potentiator
Ivacaftor for Chronic Sinusitis
Phase < 1
Recruiting
Led By Bradford Woodworth, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previous surgery with (at least) exposed maxillary and ethmoid sinuses
Negative pregnancy test for females of childbearing potential within 72 hours of testing and start of study treatment
Must not have
Currently taking medications that are moderate or strong CP3A inhibitors
History of solid organ or hematological transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to day 30
Summary
This trial is testing whether a drug called ivacaftor is safe and effective in people with chronic rhinosinusitis who haven't responded to other treatments.
Who is the study for?
This trial is for adults with chronic sinusitis who've had sinus surgery, can undergo specific nasal tests, and have a recent CT scan showing sinus issues. They must not be pregnant or breastfeeding, have normal liver and kidney function, and not be on certain other medications.
What is being tested?
The study is testing Ivacaftor's safety and effectiveness in treating chronic sinusitis compared to standard care. It will check if the drug improves chloride secretion in the sinuses, reduces inflammation/infection markers, and betters disease-specific quality of life scores.
What are the potential side effects?
While side effects are being studied as part of this trial's purpose, common ones associated with Ivacaftor may include respiratory symptoms like chest tightness or shortness of breath, stomach discomforts such as abdominal pain or gas, skin rashes or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery that exposed my maxillary and ethmoid sinuses.
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I have taken a pregnancy test within the last 3 days and it was negative.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on medication that strongly affects my liver's ability to process drugs.
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I have had an organ or bone marrow transplant.
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My liver tests are more than twice the normal limit.
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I have had an asthma attack that needed emergency care or oral steroids in the last 2 months.
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I am not pregnant or breastfeeding.
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I have a history of immune, autoimmune, or granulomatous disorders.
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I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening to day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to day 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in quality of life measures
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: standard of care treatment + ivacaftorExperimental Treatment2 Interventions
topical nasal steroid spray and culture-directed antibiotics + ivacaftor 150 mg tablet
Group II: standard of care treatmentPlacebo Group1 Intervention
topical nasal steroid spray and culture-directed antibiotics
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivacaftor
2013
Completed Phase 3
~4030
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,311 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,364 Total Patients Enrolled
Bradford Woodworth, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood has high levels of creatinine.I had surgery that exposed my maxillary and ethmoid sinuses.You have tested positive for certain types of bacteria within the last 30 days.I have taken a pregnancy test within the last 3 days and it was negative.I am currently on medication that strongly affects my liver's ability to process drugs.My recent CT scan shows changes in my mucosa, bones, or has air fluid levels.I have had an organ or bone marrow transplant.My liver tests are more than twice the normal limit.I am 18 years old or older.I have had an asthma attack that needed emergency care or oral steroids in the last 2 months.I am not pregnant or breastfeeding.I have a history of immune, autoimmune, or granulomatous disorders.You need to be able to undergo a test that requires placing a catheter in your nasal cavity and sinus openings.The investigator has diagnosed you with CRS.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: standard of care treatment
- Group 2: standard of care treatment + ivacaftor
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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