NCT02038803

Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

Patient Preferences and Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution (PETIS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations of CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately, the standard nebulizer method for delivering tobramycin inhaled solution (TIS) is time-consuming and may result in missed therapy doses and suboptimal care. A new inhaled formulation and delivery device, the TOBI Podhaler (TPI), an alternative method of administering inhaled Tobramycin will be used and assessed. This new pocket-sized disposable inhaler is maintenance-free, requires no refrigeration or power source, and should greatly increase patient mobility and improve time management.

Detailed description

Adult cystic fibrosis patients from the Rush University Medical Center Adult Cystic Fibrosis Program will be recruited for a prospective before and after cohort study to evaluate patient preference for either the TOBI Podhaler or inhaled tobramycin solution and compare the efficacy of the TOBI Podhaler to tobramycin inhaled solution. This project will evaluate the potential differences in efficacy, medication adherence, treatment time, side effects/adverse effects, quality of life, and identify patient preferences between the use of TIP and TIS. Measurements after a 28-day cycle of tobramycin inhaled solution, first 28-day cycle of TOBI Podhaler and third 28-day cycle of TOBI Podhaler will include FEV1, number of acute pulmonary exacerbations, adherence, cough frequency, sputum characteristics, and side effects or adverse events. The quality of life as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be measured after a 28-day cycle of tobramycin inhaled solution and the third 28-day cycle of TOBI Podhaler. The FEV1 values, number of missed treatments, and total treatment time will be analyzed through a repeated measures analysis of variance. Comparisons of the CFQ-R data before and after the switch to the TPI will be made with the Student's t-test.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	TOBIpodhaler

Timeline

• Start date: 2013-10-10
• Primary completion: 2014-05-07
• Completion: 2014-05-07
• First posted: 2014-01-17
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: United States