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

This study has been completed.
Cystic Fibrosis Foundation
Information provided by:
Children's Hospital Boston Identifier:
First received: October 17, 2007
Last updated: May 12, 2011
Last verified: May 2011

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 1

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:

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

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

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
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Please refer to this study by its identifier: NCT00547053

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Cystic Fibrosis Foundation
Principal Investigator: Dawn Ericson, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Dawn Ericson, MD, Children's Hospital, Boston 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:
Cystic Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Pharmaceutical Solutions
Acid Sensing Ion Channel Blockers
Cardiovascular Agents
Diuretics, Potassium Sparing
Epithelial Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses processed this record on November 27, 2014