Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004829
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-06
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:
OBJECTIVES I Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa
II Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response
II Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled multicenter study
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest This treatment is repeated twice for a total of 3 courses of therapy
Patients are followed every 2 weeks for the first 8 weeks then every 4 weeks and then at 4 weeks after the last treatment
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest This treatment is repeated twice for a total of 3 courses of therapy
Patients are followed every 2 weeks for the first 8 weeks then every 4 weeks and then at 4 weeks after the last treatment
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 |
|---|---|---|---|
| PATH-FDR001235 | None | None | None |
| PATH-PG-TNDS-002003 | None | None | None |