Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects (EVOLVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00125346|
Recruitment Status : Terminated (per Data Monitoring Committee recommendation)
First Posted : August 1, 2005
Last Update Posted : October 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Tobramycin Inhalation Powder||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
U.S. FDA Resources
- Forced expiratory volume in 1 second (FEV1) measured at week 1 and week 5.
- Time until first antipseudomonal antibiotic (an antibiotic used to treat bacteria of a certain type [the genus pseudomonas]) is used
- Relative changes in FEV1 % predicted for patients who received TIP starting at visit 1 and for patients who received placebo starting at week 9, compared to all subsequent visits.
- Relative change in FEV1 % predicted for patients who received placebo from week 5 to week 13
- Relative change in FEV1 % predicted for patients who received placebo (from the average of four assessments [weeks 1, 2, 5, and 9] to week 13)
- Change from baseline in susceptibility of pseudomonas to the antibiotic during the study measured at weeks 5, 9, 13, 17, 21, and 25, and change from baseline in quantity of pseudomonas found in sputum during the study measured at weeks 5, 9, 13, 17, 21,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125346
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