Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

Status Completed

Clinical Trial 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), is a quicker, more efficient method of administering inhaled Tobramycin. 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.

Clinical Trial 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. The chi square test will be used to evaluate differences in categorical data. All tests will be tested at an alpha equal to 0.05. Responses for the adverse reactions or side effects will be listed and categorized. The percentages of patients preferring each inhaled solution will be reported. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02038803
Study type	Observational
Source	Rush University Medical Center
Contact
Status	Completed
Phase
Start date	October 2013
Completion date	May 2014

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution — PETIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms