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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to day 30
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
~2950

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,607 Total Patients Enrolled
2 Trials studying Chronic Sinusitis
100 Patients Enrolled for Chronic Sinusitis
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,334 Total Patients Enrolled
Bradford Woodworth, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Ivacaftor (CFTR Potentiator) Clinical Trial Eligibility Overview. Trial Name: NCT03439865 — Phase < 1
Chronic Sinusitis Research Study Groups: standard of care treatment, standard of care treatment + ivacaftor
Chronic Sinusitis Clinical Trial 2023: Ivacaftor Highlights & Side Effects. Trial Name: NCT03439865 — Phase < 1
Ivacaftor (CFTR Potentiator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03439865 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on other trials involving conventional medical interventions?

"At present, 14 Phase 3 studies regarding standard of care are underway. Of those 21 active trials, Bochum and California have the highest concentration; yet there are over 1,015 locations where these clinical trials take place."

Answered by AI

What is the enrollment status of this scientific experiment?

"According to information posted on clinicaltrials.gov, this investigation is currently enrolling participants. The trial was initially unveiled on May 2nd 2019 and most recently changed on June 24th 2022."

Answered by AI

What is the total capacity of participants accepted to this medical study?

"Affirmative. Clinicaltrials.gov serves as evidence that this clinical study, which was initially posted on May 2nd 2019, is still recruiting patients across a single location to fill 20 available spots."

Answered by AI

Is the design of this clinical trial unprecedented?

"At present, there are 21 ongoing studies for standard of care treatments that span 109 cities and 23 nations. In 2015, Vertex Pharmaceuticals Incorporated initiated the first such trial which involved 1044 patients and culminated in Phase 3 drug approval; since then another 86 trials have been conducted."

Answered by AI

What is usually the most commonly accepted way of treating a particular condition?

"Cystic fibrosis (CF) patients who possess the ivacaftor-responsive cftr mutation, homozygous for f508del mutation in the cftr gene can be successfully treated with standard medical procedures."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis
Brad Woodworth, MD 2019. "Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03439865.
~3 spots leftby Apr 2025
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