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...
Date First Received: October 17, 2007
Last Updated: May 8, 2008
Verified by: Children's Hospital Boston, May 2008
Clinical Trial Phase: Phase 1 | Start Date: December 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 25
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study Primary Completion Date: May 2008
Intervention(s) in this Clinical Trial
- Drug: Amiloride Solution for Inhalation
- 4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months
Outcome Measures for this Clinical Trial
Primary Measures
- Eradication of Burkholderia dolosa.
- Time Frame: 1 month, 3 months, and 6 months
Safety Issue?: Yes
- Time Frame: 1 month, 3 months, and 6 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Children's Hospital Boston
Overall Clinical Trial Officials and Contacts
Dawn Ericson, MD Principal Investigator Children's Hospital Boston
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00547053
Study ID Number: 06-06-0290
ClinicalTrials.gov Identifier: NCT00547053
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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