Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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6 January 2025 |
Main ID: |
NCT01180634 |
Date of registration:
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10/08/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
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Scientific title:
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A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients |
Date of first enrolment:
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November 4, 2010 |
Target sample size:
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330 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT01180634 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Canada
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Israel
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New Zealand
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United States
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Contacts
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Name:
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MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Amgen |
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Key inclusion & exclusion criteria
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Inclusion Criteria (selected):
- >/= 12 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa at screening and within the past 12 months
- Patients are able to elicit an FEV1 >/= 25% but screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12
months
- Clinically stable with no changes in health status within the last 28 days
- Able to reproducibly produce sputum and perform spirometry
Exclusion Criteria (selected):
- Use of any nebulized or systemic antibiotics within 28 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol
medication
- Evidence of respiratory infections within 14 days prior to dosing
- CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Aeroquin
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Drug: Placebo
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Primary Outcome(s)
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Time to an Exacerbation
[Time Frame: Baseline to end of study (up to 59 days)]
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Secondary Outcome(s)
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Change From Baseline in Pseudomonas Aeruginosa Sputum Density
[Time Frame: Baseline, Day 28]
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Relative Change From Baseline in Percent Predicted FEV1
[Time Frame: Baseline, Day 28]
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Time to First Hospitalization
[Time Frame: Baseline to end of study (up to 59 days)]
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Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)
[Time Frame: Baseline, day 28]
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Number of Participants With Treatment Emergent Adverse Events
[Time Frame: From start of study until end of study (Up to 59 days)]
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Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials
[Time Frame: Baseline to end of study (up to 59 days)]
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Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)
[Time Frame: Baseline, Day 28]
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Secondary ID(s)
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2010-019515-38
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Mpex-207
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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