A 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

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: LLTClassification code 10021860Term: Infection Pseudomonas aeruginosaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-004318-82-Outside-EU/EEA
• Lead Sponsor: ovartis Pharmaceuticals Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

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.
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

Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Change from baseline in Forced Expiratory Volume in 1 second ( FEV1) percent predicted [ Time Frame: Baseline and Day 168 ]<br>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.;Timepoint(s) of evaluation of this end point: Time Frame: Baseline and Day 168