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Completed

NCT Number: NCT00274391

Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7% NaCl

Drug

Amiloride HCl

Drug

Primary outcomes

  1. FEV1

Secondary outcomes

  1. Mucociliary clearance rate

  2. Quality of Life

  3. FVC

  4. FEF25-75

  5. Cough clearance rate

Sponsors and collaborators

Lead sponsor

University of North Carolina

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Important dates

Study start
2001
Study completion
2004
First posted
Jan 10, 2006
Registry last updated
Jan 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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