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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 Therapeutics
Information provided by:
Boston Children’s Hospital 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 Boston Children’s Hospital:

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   (Child, Adult, Senior)
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
Boston Children’s Hospital
Cystic Fibrosis Foundation Therapeutics
Principal Investigator: Dawn Ericson, MD Boston Children’s Hospital
  More Information

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
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions
Natriuretic Agents
Physiological Effects of Drugs
Acid Sensing Ion Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Epithelial Sodium Channel Blockers
Diuretics, Potassium Sparing
Anti-Bacterial Agents
Anti-Infective Agents processed this record on October 26, 2016