Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02038803 |
| Other study ID # |
13080201 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2013 |
| Est. completion date |
May 2014 |
Study information
| Verified date |
April 2021 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
