Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis

January 9, 2006 updated by: University of North Carolina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
FEV1

Secondary Outcome Measures

Outcome Measure
Quality of Life
Mucociliary clearance rate
FVC
FEF25-75
Cough clearance rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina

Collaborators

Cystic Fibrosis Foundation

Investigators

  • Principal Investigator: Scott H. Donaldson, MD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion

December 7, 2022

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2006

Last Update Submitted That Met QC Criteria

January 9, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DONALDS00A0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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