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

NCT ID: NCT02015663

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Tobramycin Inhalation Powder

Intervention Type: DRUG

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

Arm 2

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

Group Type: ACTIVE_COMPARATOR

Tobramycin Inhalation Powder

Intervention Type: DRUG

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

Interventions

Tobramycin Inhalation Powder

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Mobile, Alabama, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Sacramento, California, United States

Novartis Investigative Site

Ventura, California, United States

Novartis Investigative Site

Altamonte Springs, Florida, United States

Novartis Investigative Site

Jacksonville, Florida, United States

Novartis Investigative Site

Miami, Florida, United States

Novartis Investigative Site

Orlando, Florida, United States

Novartis Investigative Site

Pensacola, Florida, United States

Novartis Investigative Site

Glenview, Illinois, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

Iowa City, Iowa, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

New Hyde Park, New York, United States

Novartis Investigative Site

New York, New York, United States

Novartis Investigative Site

Akron, Ohio, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Portland, Oregon, United States

Novartis Investigative Site

Hershey, Pennsylvania, United States

Novartis Investigative Site

Austin, Texas, United States

Novartis Investigative Site

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

CTBM100CUS03

Identifier Type: -

Identifier Source: org_study_id