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

NCT02015663 | Terminated Phase 4 Results

• 1 other identifier: CTBM100CUS03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; CF

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted

  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 Outcomes (11)

• Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted

  Baseline and Day 168

• Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted

  Baseline and Day 168

• Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted

  Baseline and day 168

• Change From Baseline in Pseudomonas Aeruginosa Sputum Density

  Baseline and day 168

• Time to First Hospitalization Due to Respiratory-related Events

  Day 1 to day 168

Study Arms (2)

Arm 1

EXPERIMENTAL

Tobramycin Inhalation Powder (112 mg) once daily during 168 days

Drug: Tobramycin Inhalation Powder

Arm 2

ACTIVE COMPARATOR

Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140

Drug: Tobramycin Inhalation Powder

Interventions

Tobramycin Inhalation Powder DRUG

Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm

Arm 1; Arm 2

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Confirmed diagnosis of CF
• FEV1 at screening (Visit 1) ≥25% and ≤ 80% of normal predicted values for age, sex, and height
• P. aeruginosa must be present within 6 months prior to screening and at screening
• Able to comply with all protocol requirements
• Clinically stable in the opinion of the investigator

You may not qualify if:

• History of Burkholderia cenocepacia (Bcc) complex within 2 years prior to screening and/or Bcc complex at screening
• Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration
• History of hearing loss or chronic tinnitus deemed clinically significant by the investigator
• 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
• Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
• Patients who are unable to discontinue previously received inhaled antibiotic regimen(s) (inhaled antibiotics are not allowed other than study drug)
• Use of inhaled aminoglycosides within 28 days prior to study drug administration (Visit 2)
• Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
• Use of loop diuretics within 7 days prior to study drug administration
• Administration of any investigational drug within 30 days prior to enrollment or 5 half-lives, whichever is longer
• Signs and symptoms of acute pulmonary disease, e.g , pneumonia, pneumothorax
• Hospitalization during the baseline visit
• History of malignancy
• Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
• Patients with other clinically significant conditions (not associated with the study indication) which might interfere with the assessment of this study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (21)

Novartis Investigative Site

Mobile, Alabama, 36608-1128, United States

Location

Novartis Investigative Site

Los Angeles, California, 90027, United States

Location

Novartis Investigative Site

Sacramento, California, 95819, United States

Location

Novartis Investigative Site

Ventura, California, 93003, United States

Location

Novartis Investigative Site

Altamonte Springs, Florida, 32701, United States

Location

Novartis Investigative Site

Jacksonville, Florida, 32207, United States

Location

Novartis Investigative Site

Miami, Florida, 33136, United States

Location

Novartis Investigative Site

Orlando, Florida, 32806, United States

Location

Novartis Investigative Site

Pensacola, Florida, 32504, United States

Location

Novartis Investigative Site

Glenview, Illinois, 60025, United States

Location

Novartis Investigative Site

Indianapolis, Indiana, 46202, United States

Location

Novartis Investigative Site

Iowa City, Iowa, 52242, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63104, United States

Location

Novartis Investigative Site

New Hyde Park, New York, 11040, United States

Location

Novartis Investigative Site

New York, New York, 10595, United States

Location

Novartis Investigative Site

Akron, Ohio, 44308, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73112, United States

Location

Novartis Investigative Site

Portland, Oregon, 92772, United States

Location

Novartis Investigative Site

Hershey, Pennsylvania, 17033-8050, United States

Location

Novartis Investigative Site

Austin, Texas, 78723, United States

Location

Novartis Investigative Site

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Due to premature termination, summaries and analyses planned in the protocol were eliminated in the statistical analysis plan prior to database lock. No inferential analysis will be provided.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (21)