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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: TOBIpodhaler

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult (≥ 18 years) diagnosed with cystic fibrosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adults- Cystic Fibrosis; Adults with cystic fibrosis who have respiratory colonization with Pseudomonas Aeruginosa. The actual study will involve instructing adult patients with CF on the use of a new form of Tobramycin for inhalation (powder) and then assessing this new form of TOBI podhaler vs the old TOBI solution related to patient preference on use, time involved in taking the new medication vs the old, and impact on their pulmonary function and subsequent exacerbation rate plus quality of life.

Drug: TOBIpodhaler; Other Names: Inhaled TOBI solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased Adherence to the Medical Therapeutic Regimen	Number of Participants with Adherence to Tobramycin Inhaled Solution Treatment compared with TOBI Podhaler Treatment based on improved efficacy and time required for administration and translate into improved respiratory status for adult patients with cystic fibrosis.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference for TOBIpodhaler Treatment	The subject will indicate a preference for TOBIpodhaler vs prior treatment.	6 months
Spirometry Data	spirometry was performed at baseline and at the end of the study.	6 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Robert A Balk, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2013
• Primary Completion (Actual): May 7, 2014
• Study Completion (Actual): May 7, 2014

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 15, 2014
• First Posted (Estimated): January 17, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cystic Fibrosis Medication Adherence
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 13080201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No