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Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

NCT02038803 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2024-12-06

Study results available
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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

Interventions

DRUG

TOBIpodhaler

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Robert A Balk, MD · Rush University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-10
Primary Completion
2014-05-07
Completion
2014-05-07

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02038803 on ClinicalTrials.gov