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

Information source: Children's Hospital Boston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Amiloride Solution for Inhalation (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Dawn Ericson, MD, Principal Investigator, Affiliation: Children's Hospital Boston

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eradication of Burkholderia dolosa.

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: December 2006
Last updated: May 12, 2011

Page last updated: August 23, 2015

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