Back to resultsAmiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amiloride Solution for Inhalation
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility 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
Sites / Locations
- Children's Hospital
Outcomes
Primary Outcome Measures
Eradication of Burkholderia dolosa.
Secondary Outcome Measures
Full Information
NCT ID
NCT00547053
First Posted
October 17, 2007
Last Updated
May 12, 2011
Sponsor
Boston Children's Hospital
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00547053
Brief Title
Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amiloride Solution for Inhalation
Intervention Description
4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months
Primary Outcome Measure Information:
Title
Eradication of Burkholderia dolosa.
Time Frame
1 month, 3 months, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Ericson, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
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