Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

NCT00274391 | Completed Phase 2

• 1 other identifier: DONALDS00A0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• FEV1

Secondary Outcomes (5)

• Mucociliary clearance rate

• Quality of Life

• FVC

• FEF25-75

• Cough clearance rate

Interventions

7% NaCl DRUG

Amiloride HCl DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of CF
• gene mutations identified, or
• Sweat chloride \> 60 mmol/L, and
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Amiloride

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Scott H. Donaldson, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 10, 2006
• Study Start: July 1, 2001
• Study Completion: April 1, 2004
• Last Updated: January 10, 2006

Record last verified: 2005-12

Locations

US (1)