Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
Information source: Children's Hospital Boston
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Amiloride Solution for Inhalation (Drug)
Phase: Phase 1
Status: Active, not recruiting
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: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
Ending date: June 2008
Last updated: May 8, 2008
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