Status:
COMPLETED
Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
Lead Sponsor:
Joseph Zabner
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown ...
Detailed Description
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Disruption of the cystic fibrosis transmembrane conductance regulator chlor...
Eligibility Criteria
Inclusion
- Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
- Age 12 or greater
- FEV1 \> 30% predicted(within the last 14 days and oxygen saturation \> 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
- Admitted for an exacerbation,
- Use of effective contraception in women,
- Able to provide written informed consent.
Exclusion
- Pregnancy,
- History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
- Hemoptysis more than 60 mL within the last 30 days,
- Use of any investigational study drug within the last 30 days,
- Initiation of hypertonic saline within the last 30 days,
- A serum creatinine 2 mg/dl or more
- Active malignancy in the last year
- Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
- B cepacia colonization
- Waiting list for lung transplant
- Lack of FEV1 data from the last 14 days
- Previous participation in this study
Key Trial Info
Start Date :
January 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00928135
Start Date
January 22 2013
End Date
April 9 2018
Last Update
June 25 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242