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Cystic FibrosisPhase 3TISNCT01270347

Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

A Phase 3 study testing MP-376 (Levofloxacin Solution for Inhalation) and TIS (Tobramycin Inhalation Solution) in people with Cystic Fibrosis, run by Amgen at 130 sites in 6 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?
MP-376 (Levofloxacin Solution for Inhalation) and TIS (Tobramycin Inhalation Solution)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
130 sitesin 6 countries
Study dates
Jan 2011to Jun 2013
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 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 tobramycin 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 inhaled or systemic aminoglycosides including tobramycin or any excipients
  • Evidence of acute upper within 10 days or lower respiratory infections within 28 days prior to dosing
  • CrCl < 20 at Screening
  • History of lung transplantation
  • Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate in the open label extension as long as they complete Visit 7 (Day 168), provide informed consent for participation in the open label extension of in the study and are clinically stable, as assessed by the Investigator.

Trial locations and contacts

130 sites in 6 countries.

130 sites in 6 countries

United States99 sites

  • Study site

    Akron, Ohio, 44308

  • Albany Medical College #2

    Albany, New York, 12208

  • 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

    Baltimore, Maryland, 21287

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115

  • 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

    Durham, North Carolina, 27710

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Gainesville, Florida, 32610

  • 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, 43202

  • 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

    Little Rock, Arkansas, 72202

  • Study site

    Livingston, New Jersey, 07039

  • Study site

    Long Beach, California, 90806

  • 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

    Milwaukee, Wisconsin, 53266

  • 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 Haven, Connecticut, 65020

  • Study site

    New Hyde Park, New York, 11042

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10032

  • Study site

    Niles, Illinois, 60714

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Oakland, California, 94611

  • Oklahoma CF Center

    Oklahoma City, Oklahoma, 73104

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Omaha, Nebraska, 68105

  • Study site

    Orange, California, 92868

  • Study site

    Orlando, Florida, 32801

  • Study site

    Palo Alto, California, 94304

  • Study site

    Peoria, Illinois, 61637

  • 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 Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98105

  • Study site

    Sioux Falls, South Dakota, 57117

  • 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

Germany11 sites

  • Charité Campus Virchow-Klinikum

    Berlin

  • Universitätskinderklinik Dresden Mukoviszidose-Ambulanz

    Dresden

  • Universitätsklinikum Essen

    Essen

  • Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin

    Gieben

  • Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro

    Hamburg

  • Universitätsklinikum Kiel

    Kiel

  • Ludwig-Maximilians Universität Klinikum Innenstadt

    München

  • Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz

    Munich

  • Universitätsklinik für Kinder- und Jugendmedizin

    Tübingen

Other trials in Germany

France6 sites

  • Hôpital Pellegrin Enfants - CHU Bordeaux

    Bordeaux, 33076

  • CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve

    Montpellier, 34295

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Necker-Enfants Malades

    Paris, 75743

  • Hôpital Haut-Lévêque CHU de Bordeaux

    Pessac, 33604

  • CRCM adulte Hôpital Larrey-CHU de Toulouse

    Toulouse, 31059

Other trials in France

United Kingdom6 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Birmingham Heartlands Hospital

    Birmingham, B95SS

  • Castle Hill Hospital

    Cottingham, HU16 5JQ

  • St James's University Hospital

    Leeds, LS97TF

  • King's College Hospital

    London, SE59RS

  • University Hospital Llandough, Penarth

    Penarth, CF64 2XX

Other trials in United Kingdom

Ireland4 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • National Children's Hospital Tallaght

    Dublin

  • St. Vincent's University Hospital

    Dublin

Other trials in Ireland

Israel4 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Medical Center Mount Scopus

    Jerusalem, 91240

  • Schneider Childrens Medical Center of Israel

    Petah Tikva, 49202

  • Safra Childrens Hospital, Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

About this study

Official title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable 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 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.

Read the detailed description

This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals] over three consecutive cycles of 28-days treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will also be compared, as well as explored over multiple treatment cycles.

Study patients participating in Mpex 209 will be given the option to participate in a six-month open label extension phase of the Mpex 209 protocol. The open label extension will allow enrolled patients to receive three additional courses of MP-376 (levofloxacin inhalation solution, Aeroquin™).

Study with completed results acquired from Horizon in 2024.

Conditions
Cystic Fibrosis
Being tested
MP-376 (Levofloxacin Solution for Inhalation), TIS (Tobramycin Inhalation Solution)
Medical subject headings
Cystic Fibrosis

What participants receive

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

  • MP-376 (Levofloxacin Solution for Inhalation)Drug

    Also called (Aeroquin, Levofloxacin solution for Inhalation)

    MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment

  • TIS (Tobramycin Inhalation Solution)Drug

    Also called TOBI

    Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment

Study groups in NCT01270347
Study groupRoleWhat they receive
AeroquinExperimentalAeroquin, Inhaled Levofloxacin (MP-376)
Receives: Drug: MP-376 (Levofloxacin Solution for Inhalation)
TISActive comparatorTobramycin Inhalation solution (TIS) [TOBI® Novartis Pharmaceuticals]
Receives: Drug: TIS (Tobramycin Inhalation Solution)

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    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 the study (up to 168 days)

  2. Relative Change From Baseline 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 (SE) were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, > 18 years), and Baseline FEV1 (< 55%, . 55%).

    Measured: Baseline, day 28

Secondary outcomes (8)

  1. Percent Change From Baseline in Average Expired Flow Over the Middle Half of The FVC Maneuver (FEF25-75)

    LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, >18 years), baseline FEV1 (<55%, >=55%), and baseline as a covariate.

    Measured: Baseline, day 28

  2. Percent Change From Baseline in Forced Vital Capacity (FVC)

    LSMean and SE were determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, >18 years), baseline FEV1 (<55%, >=55%), and baseline as a covariate

    Measured: Baseline, day 28

  3. Number of Participants in Each Category of Relative Change in Percent Predicted FEV1

    FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.

    Measured: Day 28

  4. Number of Participants in Each Category of Percent Change From Baseline in FEV1

    FEV1 was the volume of air exhaled in first second of a forced expiration as measured by spirometer.

    Measured: Day 28

  5. Change From Baseline in Pseudomonas Aeruginosa Sputum Density

    Pseudomonas aeruginosa density was measured as log10 colony-forming units [CFU] per gram sputum.

    Measured: Baseline, day 28

  6. Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density

    Pseudomonas aeruginosa density was measured as log10 colony-forming units [CFU] per gram sputum.

    Measured: Baseline, day 28

  7. 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.

    Measured: Baseline, day 28

  8. Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of 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.

    Measured: Baseline, day 28

Timeline

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

  1. First posted5 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2012
  4. Study completionJun 2013

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
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01270347
Sponsor's protocol ID
Mpex-209
Other IDs
2010-019634-26
Acronym
TIS
Status last verified
Nov 2024
First submitted
3 Jan 2011
Last updated
13 Dec 2024
Data monitoring committee
Yes

Publications

  • Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

    PubMed 26935334

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MP-376 (Levofloxacin Solution for Inhalation) and TIS (Tobramycin Inhalation Solution) in people with Cystic Fibrosis, run by Amgen at 130 sites in 6 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 6 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 13 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 130 sites in United States, Germany, France, United Kingdom, Ireland and 1 more country. 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. 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 21 May 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From start of study until end of the study (up to 168 days)). The study lists 2 primary outcomes in all. 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 NCT01270347, which also lists 1 linked publication.

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 13 Dec 2024.

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