Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

Last updated: October 17, 2024
Sponsor: Rush University Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Cystic Fibrosis

Scar Tissue

Lung Disease

Treatment

TOBIpodhaler

Clinical Study ID

NCT02038803
13080201
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (≥ 18 years) diagnosed with cystic fibrosis

  2. Airway colonization with Pseudomonas aeruginosa that is sensitive to tobramycin invitro and currently managed with Tobramycin inhaled solution who are interested inswitching to the TOBI Podhaler.

Exclusion

Exclusion Criteria:

  1. Persons unable to communicate in English,

  2. Pregnant patients,

  3. Patients < 18 years of age

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: TOBIpodhaler
Phase:
Study Start date:
October 10, 2013
Estimated Completion Date:
May 07, 2014

Study 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.

Connect with a study center

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

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