Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479258
Status:
TERMINATED
Last Update Posted:
2018-10-01
First Post:
2007-05-24
Brief Title:
Safety And Efficacy Of Exubera Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Safety And Efficacy Of Exubera Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy In Children And Adolescents Ages 6-17 Years With Type 1 Diabetes Mellitus A 12 Month Outpatient Randomized Open Label Parallel Group Comparative Trial
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See termination reason in detailed description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period
Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera At that time recruitment for the pediatric study A2171083 was placed on hold Two subjects completed the informed consentassent process and entered the A2171083 study but none received treatment The first subject withdrew consent during the Baseline Run-in period which was prior to Randomization The second subject screen failed at Visit 1 After this time Nektar the company from which Pfizer licensed Exubera announced on April 9 2008 that it had stopped its search for a new marketing partner Accordingly there will be no commercial availability of Exubera As a result study A2171083 was terminated and no further recruitment took place
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