Early Phase 1 Chronic Rhinosinusitis Trial, Recruiting NCT03439865 Sponsor: University of Alabama at Birmingham Condition: Chronic Rhinosinusitis
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Early Phase 1 Chronic Rhinosinusitis Trial, Recruiting

NCT03439865
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You are willing and able to give your consent to take part in the trial
  • You have been diagnosed with chronic rhinosinusitis (long-term sinus inflammation) by one of the trial doctors
  • You have had a CT scan within the last 30 days that clearly shows sinus problems such as swelling of the sinus lining, bone changes, or fluid in the sinuses
  • A recent test (within the last 30 days) has shown a specific type of bacteria called gram-negative bacteria (such as Pseudomonas or E. coli) growing in your sinuses
  • You have previously had sinus surgery that opened up at least your maxillary (cheek) and ethmoid (between-the-eyes) sinuses
  • Your nasal passages and sinus openings are wide enough to allow a small tube (catheter) to be placed for the trial's testing procedure
  • If you are a woman who could become pregnant, you have had a negative pregnancy test within 72 hours before starting the study treatment

Who may not be able to join:

  • You are under 18 years of age
  • You have had an acute (sudden) illness other than a sinus infection within the past 2 weeks that the trial doctor believes would prevent safe participation
  • You are currently taking certain medications that are classified as moderate or strong CYP3A inhibitors (confirm with trial site)
  • You have had an asthma attack in the last 2 months that required a trip to the emergency room or treatment with steroid tablets
  • You have had a transplant of a solid organ (such as a kidney or liver) or a blood/bone marrow transplant
  • You have a known immune system disorder, autoimmune condition, or a granulomatous disease (a specific type of inflammatory condition) (confirm with trial site)
  • Your kidney function blood test results are significantly above the normal range (confirm with trial site)
  • Your liver function blood test results are significantly above the normal range
  • You are currently pregnant or breastfeeding

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Bradford Woodworth, MD, University of Alabama at Birmingham

Phone: (205) 975-6169

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
2 May 2019
Est. completion
1 April 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Improvement in quality of life measures

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov