A Phase 3 interventional study of Tobramycin Inhalation Powder in Cystic Fibrosis, sponsored by Novartis. Terminated at 41 sites in 8 countries. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2011-10-12.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 98 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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,
This study is terminated, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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