Status:
TERMINATED
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than f...
Detailed Description
This study was terminated prematurely. The reason for trial termination was challenge with enrollment and patient recruitment. A significant decrease in the eligible patient population had been identi...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CF
- Patients with elevated LCI of ≥ 7.5 at screening
- Patients with FEV1 of ≥ 50% predicted at screening
- Use of inhaled Tobramycin in a 28 days on / off regimen in the past 3 months before screening
- chronic lung Infection with Pseudomonas aeruginosa
Exclusion
- Patients who are regularly receiving more than one class of inhaled anti-pseudomonal antibiotic
- Patients who have used oral or intravenous anti-pseudomonal antibiotics within 28 days prior to on-phase of study drug
- Pregnant or nursing (lactating) women
- Change in dose, formulation or strength of the study drug in the past treatment cycle before screening
- History of hearing loss or chronic tinnitus
- Infection with Burkholderia cenocepacia complex
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02248922
Start Date
January 27 2015
End Date
April 10 2017
Last Update
October 9 2018
Active Locations (6)
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1
Novartis Investigative Site
Dresden, Germany, 01307
2
Novartis Investigative Site
Erlangen, Germany, 91054
3
Novartis Investigative Site
Essen, Germany, 45147
4
Novartis Investigative Site
Frankfurt, Germany, 60590