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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01180634
Registration number
NCT01180634
Ethics application status
Date submitted
10/08/2010
Date registered
12/08/2010
Date last updated
30/04/2024
Titles & IDs
Public title
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
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Scientific title
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
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Secondary ID [1]
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2010-019515-38
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Secondary ID [2]
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Mpex-207
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Aeroquin
Treatment: Drugs - Placebo
Experimental: Aeroquin 240 mg - Participants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.
Placebo comparator: Placebo - Participants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.
Treatment: Drugs: Aeroquin
Inhalation Solution
Treatment: Drugs: Placebo
Inhalation Solution
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to an Exacerbation
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Assessment method [1]
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The start of the exacerbation was determined by the earliest date at which a participant concurrently met at least 4 of the 12 modified Fuchs symptoms/signs; discontinued from the study early; died; or received an antipseudomonal agent for an event that did not meet modified Fuchs criteria but was determined to be an exacerbation by the Blinded Exacerbation.
Fuchs symptoms/signs;
* Change in sputum
* New or increased hemoptysis
* Increased cough
* Increased dyspnea
* Malaise, fatigue or lethargy
* Temperature above 38oC
* Anorexia or weight loss
* Sinus pain or tenderness
* Change in sinus discharge
* Change in physical examination of the chest
* Decrease in pulmonary function by 10 percent or more from a previously recorded value
* Radiographic changes indicative of pulmonary infection
Median and 95%Ci were estimated using Kaplan Meier estimates.
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Timepoint [1]
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Baseline to end of study (up to 59 days)
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Secondary outcome [1]
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Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)
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Assessment method [1]
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FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).
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Timepoint [1]
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Baseline, day 28
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Secondary outcome [2]
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Change From Baseline in Pseudomonas Aeruginosa Sputum Density
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Assessment method [2]
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Pseudomonas aeruginosa density was measured as log10 colony-forming units \[CFU\] per gram sputum. LSMean and standard are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.
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Timepoint [2]
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Baseline, Day 28
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Secondary outcome [3]
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Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)
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Assessment method [3]
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The Cystic Fibrosis Questionnaire (CFQ-R) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. LSMean and standard error were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, = 55%), and Baseline value.
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Timepoint [3]
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Baseline, Day 28
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Secondary outcome [4]
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Relative Change From Baseline in Percent Predicted FEV1
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Assessment method [4]
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FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer. Least squares (LS) mean and standard error are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).
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Timepoint [4]
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Baseline, Day 28
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Secondary outcome [5]
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Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials
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Assessment method [5]
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Participants who had at least one of four worsening respiratory symptoms (increased cough, increased sputum/chest congestion, decreased exercise tolerance, decreased appetite) at the time of administration of the anti-pseudomonal antimicrobial agent were included in the analysis. Median and 95% CI are estimated using Kaplan Meier estimates.
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Timepoint [5]
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Baseline to end of study (up to 59 days)
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Secondary outcome [6]
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Time to First Hospitalization
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Assessment method [6]
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Median and 95%CI was estimated using Kaplan Meier estimates.
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Timepoint [6]
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Baseline to end of study (up to 59 days)
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Secondary outcome [7]
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Number of Participants With Treatment Emergent Adverse Events
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Assessment method [7]
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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 episodic event or condition
* A condition first detected or diagnosed after Study Drug administration even though the condition may have been present before the start of the study
* Overdose of Study Drug
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Timepoint [7]
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From start of study until end of study (Up to 59 days)
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Eligibility
Key inclusion criteria
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 </= 85% of predicted value at 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
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Minimum age
12
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/11/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/05/2012
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Sample size
Target
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Accrual to date
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Final
330
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Westmead Chilren's Hospital - Westmead
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Mater Miscericordiae Hospital - Brisbane
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Recruitment hospital [4]
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- Brisbane
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Recruitment hospital [5]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [6]
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Royal Children's Hospital - Melbourne
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Recruitment hospital [7]
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The Alfred Hospital - Melbourne
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Recruitment hospital [8]
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Monash Medical Center - Melbourne
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Recruitment hospital [9]
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John Hunter Hospital - New South Wales
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Recruitment postcode(s) [1]
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- Westmead
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- Brisbane
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- Adelaide
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- Melbourne
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- New South Wales
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Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Haifa
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Jerusalem
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Petah Tikva
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Ramat-Gan
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New Zealand
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Horizon Pharma USA, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Forest Laboratories
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Ethics approval
Ethics application status
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Summary
Brief 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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.
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Trial website
https://clinicaltrials.gov/study/NCT01180634
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Patrick Flume, M.D.
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Address
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Medical University of South Carolina
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01180634
Download to PDF