Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274391
• Other study ID #: DONALDS00A0
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2006
• Last updated: January 9, 2006
• Start date: July 2001
• Est. completion date: April 2004

Study information

• Verified date: December 2005
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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) patients. In CF, airway secretions are thick and dehydrated. Many patients use inhaled salt solutions to help draw water into their secretions so that they are easier to get rid of with chest physiotherapy (“chest PT”) and cough. Unfortunately, these salt solutions are reabsorbed very quickly by the airways, so the beneficial effects may not last very long. In the hopes of prolonging their effects, the drug amiloride could be used in combination to slow salt and water reabsorption from airways. Amiloride is a medication that has been given by mouth for high blood pressure for many years. It is possible that the combination of salt solutions and inhaled amiloride may significantly improve the clearance of secretions in CF, which would be expected to improve lung function in CF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• 7% NaCl

• Amiloride HCl

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1
Secondary	Mucociliary clearance rate
Secondary	Quality of Life
Secondary	FVC
Secondary	FEF25-75
Secondary	Cough clearance rate