Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006280
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2000-09-11
Brief Title:
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This studys primary goals are to test the safety and effectiveness of Tobramycin for Inhalation TOBIr in cystic fibrosis CF patients who are between 6 months and 6 years of age This drug is an antibiotic that is inhaled into the lungs by the patient It has already been studied and approved by the FDA for treatment of CF patients 6 years and older Lung fluid will be examined for bacteria before and after the 28-day treatment The amount of bacteria before and after treatment will be compared This will indicate whether the antibiotic was effective in killing bacteria in the lungs Once treatment begins patients will be monitored every 2 weeks throughout the study 5 exams in 56 days Half of the patients will receive TOBIr half will receive a placebo a substance that looks like TOBIr but contains no medication
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK057755-01 | NIH | None | None |
| M01RR000037 | NIH | None | httpsreporternihgovquickSearchM01RR000037 |