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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02015663
• Date of registration: 13/12/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
• Scientific title: 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
• Date of first enrolment: January 2014
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02015663
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.

Other protocol-defined inclusion/exclusion criteria may apply.



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Tobramycin Inhalation Powder

Primary Outcome(s)

Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted [Time Frame: Baseline and Day 168]

Secondary Outcome(s)

Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted [Time Frame: Baseline and Day 168]

Percentage of Patients Who Use Anti-pseudomonal Antibiotic [Time Frame: Day 1 to day 168]

Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted [Time Frame: Baseline and day 168]

Change From Baseline in Pseudomonas Aeruginosa Sputum Density [Time Frame: Baseline and day 168]

Time to First Hospitalization Due to Respiratory-related Events [Time Frame: Day 1 to day 168]

Length of Hospital Stay Due to Respiratory-related Events [Time Frame: Day 1 to day 168]

Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa [Time Frame: Baseline and day 168]

Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted [Time Frame: Baseline and Day 168]

Duration of Use of Anti-pseudomonal Antibiotic [Time Frame: Day 1 to day 168]

Percentage of Patients With Hospitalizations Due to Respiratory-related Events [Time Frame: Day 1 to day 168]

Time to First Usage of Anti-pseudomonal Antibiotic [Time Frame: Day 1 to day 168]

Secondary ID(s)

CTBM100CUS03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02015663