Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

NCT02038803 | Terminated Results

• 1 other identifier: 13080201
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Preference for TOBIpodhaler Treatment

  6 months

• Spirometry Data

  6 months

Study Arms (1)

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

Interventions

TOBIpodhaler DRUG

Also known as: Inhaled TOBI solution

Adults- Cystic Fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult (≥ 18 years) diagnosed with cystic fibrosis

You may qualify if:

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

You may not qualify if:

• Persons unable to communicate in English,
• Pregnant patients,
• Patients \< 18 years of age

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Limitations and Caveats

There was limited enrollment and lack of follow up survey completion. Study was terminated early.

Results Point of Contact

• Title: Dr. Robert Balk
• Organization: Rush University Medical Center

Robert_Balk@rush.edu

3129426744

Study Officials

• Robert A Balk, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: October 10, 2013
• Primary Completion: May 7, 2014
• Study Completion: May 7, 2014
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)