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

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ClinicalTrials.gov Identifier: NCT00547053
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : May 13, 2011
Cystic Fibrosis Foundation
Information provided by:
Boston Children's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Amiloride Solution for Inhalation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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

Primary Outcome Measures :
  1. Eradication of Burkholderia dolosa. [ Time Frame: 1 month, 3 months, and 6 months ]

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547053

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United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Cystic Fibrosis Foundation
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Principal Investigator: Dawn Ericson, MD Boston Children's Hospital
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Responsible Party: Dawn Ericson, MD, Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00547053    
Other Study ID Numbers: 06-06-0290
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
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