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NCT02038803 · ClinicalTrials.gov registry record
Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution
A clinical trial, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- 5
- Enrollment target
NCT02038803: Clinical Trial study, sponsored by Rush University Medical Center.
NCT02038803 is a clinical trial that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02038803 was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- 5 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG TOBIpodhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-10-10 |
| Est. Completion | 2014-05-07 |
Why NCT02038803 stopped before completion
NCT02038803 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which TOBIpodhaler is the first listed.
NCT02038803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02038803 about?
NCT02038803 is a clinical study titled "Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution". 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 inh...
What is the current status of trial NCT02038803?
This trial is currently terminated. The enrollment target is 5 participants. The study started on 2013-10-10. Estimated completion is 2014-05-07.
What interventions are being tested in trial NCT02038803?
The interventions under investigation include: TOBIpodhaler (DRUG).
Who is sponsoring clinical trial NCT02038803?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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