Clinical Trial Results:
A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.
Summary
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|
EudraCT number |
2009-016734-26 |
Trial protocol |
EE LV LT BG |
Global completion date |
19 Mar 2012
|
Paediatric regulatory details
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|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
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|
Results version number |
v2(current) |
This version publication date |
29 Sep 2021
|
First version publication date |
07 Oct 2016
|
Other versions |
v1 |
Version creation reason |
|
Summary report(s) |
CTBM100C2303E2.CTR.01Sept2016 full results |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.