Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis

This study is ongoing, but not recruiting participants.

First Received: October 17, 2007 Last Updated: May 8, 2008 History of Changes

Sponsor:	Children's Hospital Boston
Collaborator:	Cystic Fibrosis Foundation
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00547053

Purpose

The purpose of this research study is to determine if multiple doses of two inhaled drugs will help Cystic Fibrosis patients whose lungs are infected with a bacteria called Burkholderia dolosa. The names of these drugs are tobramycin solution for inhalation and amiloride solution for inhalation. Currently, treating patients with Burkholderia dolosa infections is challenging because the bacteria is resistant to antibiotics. Therefore, researchers are looking for drugs which, when taken with an antibiotic, will help the antibiotic to work more effectively.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Amiloride Solution for Inhalation	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Six Month Open Label Study of Amiloride Solution for Inhalation and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Antibiotics Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate Amiloride

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:

Eradication of Burkholderia dolosa. [ Time Frame: 1 month, 3 months, and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	December 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Cystic Fibrosis
Two positive cultures for Burkholderia dolosa lung infection

Exclusion Criteria:

Positive pregnancy test or currently breast feeding (if applicable)
Known sensitivity to Amiloride

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547053

Locations

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Children's Hospital Boston

Cystic Fibrosis Foundation

Investigators

Principal Investigator:

Dawn Ericson, MD

Children's Hospital Boston

More Information

No publications provided

Responsible Party:	Children's Hospital, Boston ( Dawn Ericson, MD )
Study ID Numbers:	06-06-0290
Study First Received:	October 17, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00547053 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Tobramycin
Fibrosis
Physiological Effects of Drugs
Diuretics
Amiloride
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Anti-Bacterial Agents

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 09, 2009