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Cystic FibrosisPhase 3NCT01180634

MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

A Phase 3 study testing Aeroquin in people with Cystic Fibrosis, run by Amgen at 112 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
Aeroquin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
112 sitesin 5 countries
Study dates
4 Nov 2010to 7 May 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • >/= 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

Who cannot join

  • 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

Trial locations and contacts

112 sites in 5 countries.

112 sites in 5 countries

United States95 sites

  • Study site

    Akron, Ohio, 44308

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78723

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60614

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45229

  • Study site

    Colchester, Vermont, 05446

  • Study site

    Columbia, Missouri, 65212

  • Study site

    Columbia, South Carolina, 29203

  • Study site

    Columbus, Ohio, 43205

  • Study site

    Dallas, Texas, 75390

  • Study site

    Dayton, Ohio, 45404

  • Study site

    Denver, Colorado, 80206

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Glenview, Illinois, 60025

  • Study site

    Grand Rapids, Michigan, 49503

  • Study site

    Hartford, Connecticut, 06106

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    La Jolla, California, 92037

  • Study site

    Las Vegas, Nevada, 89107

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Livingston, New Jersey, 07039

  • Study site

    Long Beach, California, 90806

  • Study site

    Long Branch, New Jersey, 07440

  • Childrens Hospital

    Los Angeles, California, 90027

  • Study site

    Los Angeles, California, 90033

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Manchester, New Hampshire, 03104

  • Study site

    Memphis, Tennessee, 38105

  • Study site

    Miami, Florida, 33136

  • Study site

    Milwaukee, Wisconsin, 53201

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Morristown, New Jersey, 07962

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Orleans, Louisiana, 70011

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10011

  • Study site

    New York, New York, 10032

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Oakland, California, 94611

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Omaha, Nebraska, 68198

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32801

  • Study site

    Palo Alto, California, 94304

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Phoenix, Arizona, 85016

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Portland, Maine, 04102

  • Study site

    Portsmouth, Virginia, 23708

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78212

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94115

  • Study site

    San Francisco, California, 94143

  • Study site

    Seattle, Washington, 98105

  • Study site

    Seattle, Washington, 98195

  • Study site

    Sioux Falls, South Dakota, 57117

  • Study site

    St Louis, Missouri, 63104

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St. Petersburg, Florida, 33701

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33606

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Tyler, Texas, 75708

  • Study site

    Valhalla, New York, 10595

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Wilmington, Delaware, 19803

  • Study site

    Worcester, Massachusetts, 01655

Other trials in United States

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Mater Miscericordiae Hospital

    Brisbane, Queensland

  • Study site

    Brisbane, Queensland

  • Royal Children's Hospital

    Melbourne, Victoria

  • The Alfred Hospital

    Melbourne, Victoria

  • Monash Medical Center

    Melbourne

  • John Hunter Hospital

    New South Wales, New South Wales

  • Westmead Chilren's Hospital

    Westmead, New South Wales

  • Westmead Hospital

    Westmead, New South Wales

Other trials in Australia

Israel4 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Medical Center Mount Scopus

    Jerusalem, 91240

  • Schneider Childrens Medical Center of Israel

    Petah Tikva, 49202

  • Sheba Medical Center

    Ramat Gan, 52620

Other trials in Israel

Canada3 sites

  • Study site

    Hamilton, Ontario, L8N3Z5

  • Study site

    Kingston, Ontario, K7L5G2

  • Study site

    Ottawa, Ontario, K1H8L6

Other trials in Canada

New Zealand1 site

  • Auckland Hospital

    Auckland

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

This trial will be a double-blind, placebo-controlled study to evaluate the efficacy and safety of levofloxacin administered as MP-376 given for 28 days by the aerosol route to CF patients.

Study with completed results acquired from Horizon in 2024.

Conditions
Cystic Fibrosis
Being tested
Aeroquin, Placebo
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AeroquinDrug

    Also called MP-376, Levofloxacin Inhalation solution 240 mg

    Inhalation Solution

  • PlaceboDrug

    Inhalation Solution

Study groups in NCT01180634
Study groupRoleWhat they receive
Aeroquin 240 mgExperimentalParticipants received 240 milligrams (mg) of Aeroquin by inhalation route twice daily (BID) for a period of 28 days.
Receives: Drug: Aeroquin
PlaceboPlacebo comparatorParticipants placebo matching Aeroquin by inhalation route, BID for a period of 28 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to an Exacerbation

    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.

    Measured: Baseline to end of study (up to 59 days)

Secondary outcomes (7)

  1. Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1)

    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%).

    Measured: Baseline, day 28

  2. Change From Baseline in Pseudomonas Aeruginosa Sputum Density

    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.

    Measured: Baseline, Day 28

  3. Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R)

    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.

    Measured: Baseline, Day 28

  4. Relative Change From Baseline in Percent Predicted FEV1

    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%).

    Measured: Baseline, Day 28

  5. Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials

    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.

    Measured: Baseline to end of study (up to 59 days)

  6. Time to First Hospitalization

    Median and 95%CI was estimated using Kaplan Meier estimates.

    Measured: Baseline to end of study (up to 59 days)

  7. Number of Participants With Treatment Emergent Adverse Events

    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

    Measured: From start of study until end of study (Up to 59 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2010 (estimated)
  2. Study start4 Nov 2010
  3. Primary completion7 May 2012
  4. Study completion7 May 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01180634
Sponsor's protocol ID
Mpex-207
Other IDs
2010-019515-38
Status last verified
Dec 2024
First submitted
10 Aug 2010
Last updated
18 Dec 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aeroquin in people with Cystic Fibrosis, run by Amgen at 112 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Australia, Israel, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to an Exacerbation (time frame: Baseline to end of study (up to 59 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01180634.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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