Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03439865
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivacaftor — DRUG
    150 mg tablet PO BID x 14 days
  • standard of care treatment — DRUG
    topical nasal steroid spray and culture-directed antibiotics x 14 days

Study Details

The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).

Key Dates

Start date
May 2, 2019
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: standard of care treatment + ivacaftor
    topical nasal steroid spray and culture-directed antibiotics + ivacaftor 150 mg tablet
  • Placebo Comparator: standard of care treatment
    topical nasal steroid spray and culture-directed antibiotics

Primary Outcome Measure

Improvement in quality of life measures [ Time Frame: Screening to Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Norma Miller, RN
[email protected]
(205) 975-6169

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, AL

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