Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00274391
First received: January 9, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: 7% NaCl
Drug: Amiloride HCl
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • FEV1

Secondary Outcome Measures:
  • Mucociliary clearance rate
  • Quality of Life
  • FVC
  • FEF25-75
  • Cough clearance rate

Estimated Enrollment: 24
Study Start Date: July 2001
Estimated Study Completion Date: April 2004
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274391

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Scott H. Donaldson, MD University of North Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00274391     History of Changes
Other Study ID Numbers: DONALDS00A0
Study First Received: January 9, 2006
Last Updated: January 9, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Amiloride
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014