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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Robert A Balk, Rush University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038803
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert A Balk, Rush University Medical Center
  Purpose
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.

Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Preferences and Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution (PETIS)

Resource links provided by NLM:


Further study details as provided by Robert A Balk, Rush University Medical Center:

Primary Outcome Measures:
  • Increased adherence to the medical therapeutic regimen [ Time Frame: 3 months ]
    It is hypothesized that the improved efficacy and time required for administration will increase adherence to the medical therapeutic regimen and translate into improved respiratory status for adult patients with cystic fibrosis.


Estimated Enrollment: 15
Study Start Date: October 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult (≥ 18 years) diagnosed with cystic fibrosis
Criteria

Inclusion Criteria:

  1. Adult (≥ 18 years) diagnosed with cystic fibrosis
  2. Airway colonization with Pseudomonas aeruginosa that is sensitive to tobramycin in vitro and currently managed with Tobramycin inhaled solution who are interested in switching to the TOBI Podhaler.

Exclusion Criteria:

  1. Persons unable to communicate in English,
  2. Pregnant patients,
  3. Patients < 18 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038803


Contacts
Contact: Robert A Balk, M.D. (312) 942-6744 robert_a_balk@rush.edu
Contact: Ellen A Becker, PhD, RRT-NPS (312) 942-5000 ellen_becker@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Robert A Balk, MD    (312) 942-6744    robert_a_balk@rush.edu   
Contact: Ellen A Becker, PhD, RRT-NPS    (312) 942-5000    ellen_becker@rush.edu   
Principal Investigator: Robert A Balk, MD         
Sub-Investigator: Roisin McLaughlin, RRT, RPFT         
Principal Investigator: Ellen A Becker, PhD,RRT-NPS,RPFT,AE-C, FAARC         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Robert A Balk, MD Rush University Medical Center
  More Information

Responsible Party: Robert A Balk, Director, Division of Pulmonary and Critical Care Medicine, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02038803     History of Changes
Other Study ID Numbers: 13080201
First Submitted: January 15, 2014
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Robert A Balk, Rush University Medical Center:
Cystic Fibrosis Medication Adherence

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents


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