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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00547053 |
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Date of registration:
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17/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis
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Scientific title:
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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 |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00547053 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Dawn Ericson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Amiloride Solution for Inhalation
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Primary Outcome(s)
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Eradication of Burkholderia dolosa.
[Time Frame: 1 month, 3 months, and 6 months]
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Secondary ID(s)
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06-06-0290
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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