Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00547053
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Eradication of Burkholderia dolosa. 1 month, 3 months, and 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital
🇺🇸Boston, Massachusetts, United States