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Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00274391
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : January 10, 2006
Cystic Fibrosis Foundation
Information provided by:
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: 7% NaCl Drug: Amiloride HCl Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis
Study Start Date : July 2001
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Primary Outcome Measures :
  1. FEV1

Secondary Outcome Measures :
  1. Mucociliary clearance rate
  2. Quality of Life
  3. FVC
  4. FEF25-75
  5. Cough clearance rate

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274391

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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
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Principal Investigator: Scott H. Donaldson, MD University of North Carolina
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ClinicalTrials.gov Identifier: NCT00274391    
Other Study ID Numbers: DONALDS00A0
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: January 10, 2006
Last Verified: December 2005
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing