Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles

February 8, 2017 updated by: Novartis Pharmaceuticals

A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis

To provide efficacy and safety data comparing two dosing schedules of Tobramycin Inhalation Powder (TIP) for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608-1128
        • Novartis Investigative Site
    • California
      • Los Angeles, California, United States, 90027
        • Novartis Investigative Site
      • Sacramento, California, United States, 95819
        • Novartis Investigative Site
      • Ventura, California, United States, 93003
        • Novartis Investigative Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Novartis Investigative Site
      • Jacksonville, Florida, United States, 32207
        • Novartis Investigative Site
      • Miami, Florida, United States, 33136
        • Novartis Investigative Site
      • Orlando, Florida, United States, 32806
        • Novartis Investigative Site
      • Pensacola, Florida, United States, 32504
        • Novartis Investigative Site
    • Illinois
      • Glenview, Illinois, United States, 60025
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novartis Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Novartis Investigative Site
    • New York
      • New Hyde Park, New York, United States, 11040
        • Novartis Investigative Site
      • New York, New York, United States, 10595
        • Novartis Investigative Site
    • Ohio
      • Akron, Ohio, United States, 44308
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 92772
        • Novartis Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-8050
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78723
        • Novartis Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provide written informed consent, HIPPA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.
  2. Confirmed diagnosis of CF
  3. FEV1 at screening (Visit 1) ≥25% and ≤ 80% of normal predicted values for age, sex, and height
  4. P. aeruginosa must be present within 6 months prior to screening and at screening
  5. Able to comply with all protocol requirements
  6. Clinically stable in the opinion of the investigator

Exclusion Criteria:

  1. History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening
  2. Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration
  3. History of hearing loss or chronic tinnitus deemed clinically significant by the investigator
  4. Serum creatinine 2 mg/dL or greater, BUN 40 mg/dL or greater, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
  5. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
  6. Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug)
  7. Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
  8. Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
  9. Use of loop diuretics within 7 days prior to study drug administration
  10. Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer
  11. Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax
  12. Hospitalization during the baseline visit
  13. History of malignancy
  14. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
  15. Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study
  16. Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
  17. Pregnant or nursing (lactating) women
  18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Tobramycin Inhalation Powder (112 mg) once daily during 168 days
Drug: Tobramycin Inhalation Powder
Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm
Active Comparator: Arm 2
Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
Drug: Tobramycin Inhalation Powder
Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted
Time Frame: Baseline and Day 168
The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function.
Baseline and Day 168

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted
Time Frame: Baseline and Day 168
The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function.
Baseline and Day 168
Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted
Time Frame: Baseline and Day 168
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Baseline and Day 168
Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted
Time Frame: Baseline and day 168
The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed.
Baseline and day 168
Change From Baseline in Pseudomonas Aeruginosa Sputum Density
Time Frame: Baseline and day 168
Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum.
Baseline and day 168
Time to First Hospitalization Due to Respiratory-related Events
Time Frame: Day 1 to day 168
Time to the first hospitalization due to respiratory-related events (number of days) per patient.
Day 1 to day 168
Percentage of Patients With Hospitalizations Due to Respiratory-related Events
Time Frame: Day 1 to day 168
Percentage of patients with hospitalization due to respiratory-related events
Day 1 to day 168
Length of Hospital Stay Due to Respiratory-related Events
Time Frame: Day 1 to day 168
The number of days in length of hospital stay per patient due to respiratory-related events will be measured.
Day 1 to day 168
Time to First Usage of Anti-pseudomonal Antibiotic
Time Frame: Day 1 to day 168
Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days
Day 1 to day 168
Percentage of Patients Who Use Anti-pseudomonal Antibiotic
Time Frame: Day 1 to day 168
Percentage of patients who use anti-pseudomonal antibiotic will be assessed.
Day 1 to day 168
Duration of Use of Anti-pseudomonal Antibiotic
Time Frame: Day 1 to day 168
Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.
Day 1 to day 168
Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa
Time Frame: Baseline and day 168
Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.
Baseline and day 168

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTBM100CUS03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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