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

This study has been completed.

First Received on October 17, 2007. Last Updated on May 12, 2011 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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Study Completion Date:	January 2011
Primary Completion Date:	January 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:	Dawn Ericson, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier:	NCT00547053 History of Changes
Other Study ID Numbers:	06-06-0290
Study First Received:	October 17, 2007
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Aspiration
Cystic Fibrosis
Fibrosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

Amiloride
Tobramycin
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012