Status:
COMPLETED
Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis
Lead Sponsor:
University of North Carolina
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine whether the combination of inhaled amiloride and a concentrated salt solution is better than the salt solution itself for cystic fibrosis (CF) patien...
Eligibility Criteria
Inclusion
- Established diagnosis of CF
- 2 gene mutations identified, or
- Sweat chloride \> 60 mmol/L, and
- 1 or more typical CF clinical features
- Age \> 14 years
- Able to perform spirometry and have post-bronchodilator FEV1 \> 50% of predicted at screening
- Oxyhemoglobin saturation (by pulse oximetry) \> 92% on room air
- Able to provide informed consent
Exclusion
- Unstable lung disease:
- FEV1 \> 15% below best clinical measurement within 6 months
- Requirement for IV antibiotics within 4 weeks of screening
- Requirement for any change in pulmonary medication within 2 weeks of screening
- Evidence of reactive airways
- Clinical diagnosis of asthma
- \> 15% increase in FEV1 after bronchodilator at screening
- Hypertonic saline use within 2 weeks of screening
- Unwilling or unable to either continue or discontinue cyclical therapies (e.g. inhaled tobramycin) for the 2 weeks prior to screening and the entire study period
- Pregnancy, breast-feeding, or unwillingness to use barrier contraception during the entire study period
- History of allergy or intolerance to amiloride, hypertonic saline, quinine, albuterol, or related compounds
- Renal insufficiency (creatinine \> 1.5 mg/dl)
- Hyperkalemia (K+ \> 5.0 meq/L)
- Investigational drug use within 30 days of screening
- Radiation exposure within the past year that would exceed Federal Regulations by participating in the study
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00274391
Start Date
July 1 2001
End Date
April 1 2004
Last Update
January 10 2006
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599