Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434278
Status:
TERMINATED
Last Update Posted:
2017-05-16
First Post:
2007-02-11
Brief Title:
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease TOPIC
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated for administrative reasons There were no safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a multicenter randomized double-blind placebo-controlled study of patients with severe though stable cystic fibrosis CF whose routine treatment included Pulmozyme Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks placebo group Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None