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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: Completed Phase 3 study, sponsored by Amgen.
NCT01270347 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 282 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a Study Drug, whether or not considered related to the Study Drug. An AE could potentially be a new disease, any untoward event, or an exacerbation of a pre-existing condition. AEs included, but were not limited to: Any symptom not previously reported by the patient (medical history) An exacerbation of a pre-existing illness An increase in frequency or intensity of a pre-existing
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 |
What the finished NCT01270347 record still lists
NCT01270347 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which MP-376 (Levofloxacin Solution for Inhalation) is the first listed.
NCT01270347 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01270347's enrollment target sits among peer trials
282 1194th of 2000 higher than 807 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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