Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis - Full Text View

Sponsor:	University of North Carolina
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00274391

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 II

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cough Cystic Fibrosis Dietary Sodium

Drug Information available for: Amiloride

U.S. FDA Resources

Further study details as provided by The 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

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

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Fibrosis
Physiological Effects of Drugs
Diuretics
Amiloride
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Natriuretic Agents
Therapeutic Uses
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2009