Tobramycin Inhalation Powder Compared to TOBI in People with CF
Study Type:
Interventional
Intervention Category:
Anti-Infective
Study Sponsor:
Novartis
Study Phase:
3
Recruitment Status:
Trial Completed
Study Drug(s):
Tobramycin Inhalation Powder
Number of Participants Being Recruited:
500
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
ELIGIBILITY
Age:
>= 6 Years
FEV1:
25 - 75 Percent Predicted
P. aeruginosa status:
Positive
B. cepacia status:
Negative
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
This open-label study enrolled 553 CF patients (Age >=6) to evaluate the safety, efficacy and convenience of TIP� vs TOBI® for treating Pseudomonas aeruginosa (Pa) infection. Patients were randomized to 3 cycles of 28 days on/28 days off either TIP (112 mg BID) or TOBI (300mg BID). Increases in FEV1% predicted from baseline to Day 28 of Cycle 3 were similar between groups.
Secondary Efficacy:
Mean reduction in sputum PA density on Day 28 of Cycle 3 and the number of patients hospitalized for respiratory-related events were also similar between groups. The proportion of patients requiring new antipseudomonal antibiotics was significantly higher with TIP than TIS. Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction as determined by the modified patient self-reported Treatment Satisfaction Questionnaire for Medication (TSQM).
