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NCT01270347 · ClinicalTrials.gov registry record · Phase 3
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 282
- Enrollment target
NCT01270347 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 282 participants.
The verdict
NCT01270347, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 282 participants
- Enrollment target
Study Summary
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
Interventions
- DRUG MP-376 (Levofloxacin Solution for Inhalation)
- DRUG TIS (Tobramycin Inhalation Solution)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01270347
The ClinicalTrials.gov registry entry for NCT01270347 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MP-376 (Levofloxacin Solution for Inhalation) is the first listed.
NCT01270347 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01270347 about?
NCT01270347 is a clinical study titled "Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients". Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in...
What is the current status of trial NCT01270347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2011-01. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01270347?
The interventions under investigation include: MP-376 (Levofloxacin Solution for Inhalation) (DRUG), TIS (Tobramycin Inhalation Solution) (DRUG).
Who is sponsoring clinical trial NCT01270347?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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