Skip to main content
OpenTrials
Completed

NCT Number: NCT01270347

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Pellegrin Enfants - CHU Bordeaux, Bordeaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(selected):

  • > 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

Exclusion criteria

(selected):

  • 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.

Treatment and study plan

MP-376 (Levofloxacin solution for Inhalation)

Drug

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

Other names: (Aeroquin, Levofloxacin solution for Inhalation)

TIS (Tobramycin Inhalation Solution)

Drug

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

Other names: TOBI

Primary outcomes

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

    Time frame: From start of study until end of the study (up to 168 days)

    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

  2. Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline, day 28

    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%).

Secondary outcomes

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

    Time frame: Baseline, day 28

    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.

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

    Time frame: Baseline, day 28

    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

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

    Time frame: Day 28

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

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

    Time frame: Day 28

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

  5. Change From Baseline in Pseudomonas Aeruginosa Sputum Density

    Time frame: Baseline, day 28

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

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

    Time frame: Baseline, day 28

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

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

    Time frame: Baseline, day 28

    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.

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

    Time frame: Baseline, day 28

    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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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

Acronym: TIS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 5, 2011
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.