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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
2010-019515-38
Secondary ID [2] 0 0
Mpex-207
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to an Exacerbation
Timepoint [1] 0 0
Baseline to end of study (up to 59 days)
Secondary outcome [1] 0 0
Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)
Timepoint [1] 0 0
Baseline, day 28
Secondary outcome [2] 0 0
Change From Baseline in Pseudomonas Aeruginosa Sputum Density
Timepoint [2] 0 0
Baseline, Day 28
Secondary outcome [3] 0 0
Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)
Timepoint [3] 0 0
Baseline, Day 28
Secondary outcome [4] 0 0
Relative Change From Baseline in Percent Predicted FEV1
Timepoint [4] 0 0
Baseline, Day 28
Secondary outcome [5] 0 0
Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials
Timepoint [5] 0 0
Baseline to end of study (up to 59 days)
Secondary outcome [6] 0 0
Time to First Hospitalization
Timepoint [6] 0 0
Baseline to end of study (up to 59 days)
Secondary outcome [7] 0 0
Number of Participants With Treatment Emergent Adverse Events
Timepoint [7] 0 0
From start of study until end of study (Up to 59 days)

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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2012
Sample size
Target
Accrual to date
Final
330
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Chilren's Hospital - Westmead
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Mater Miscericordiae Hospital - Brisbane
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Royal Children's Hospital - Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Monash Medical Center - Melbourne
Recruitment hospital [9] 0 0
John Hunter Hospital - New South Wales
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- New South Wales
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Alaska
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Arizona
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California
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Colorado
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Connecticut
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Delaware
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Idaho
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Illinois
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Indiana
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Kentucky
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Louisiana
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North Carolina
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Oklahoma
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Ontario
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Haifa
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Jerusalem
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Petah Tikva
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Israel
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Ramat-Gan
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New Zealand
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Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Horizon Pharma USA, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Forest Laboratories
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01180634
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Flume, M.D.
Address 0 0
Medical University of South Carolina
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries