|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02248922 |
|
Date of registration:
|
22/09/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
ELIXIR |
|
Scientific title:
|
An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients = 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa |
|
Date of first enrolment:
|
January 27, 2015 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02248922 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Jörg Ziegler, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharma GmbH, Nürnberg, Germany |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: TIS or TIP
|
|
Primary Outcome(s)
|
|
Change From Baseline in Lung Clearance Index (LCI) After 4 Weeks Following Onset of Study
[Time Frame: Baseline, week 4]
|
|
Secondary Outcome(s)
|
|
Change From Baseline of Forced Expiratory Volume at 1 Second (FEV1) After 4 Weeks Following Onset of Study
[Time Frame: Baseline, week 4]
|
|
Change of Lung Clearance Index (LCI) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)
[Time Frame: week 4, week 8]
|
|
Change From Baseline in Lung Clearance Index (LCI) After 1 Week
[Time Frame: Baseline, week 1]
|
|
Change From Baseline of Colony-forming Units (CFU) After 4 Weeks Following Onset of Study
[Time Frame: Baseline, week 4]
|
|
Change of Colony-forming Units (CFU) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)
[Time Frame: week 4, week 8]
|
|
Change of Forced Expiratory Volume at 1 Second(FEV1) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)
[Time Frame: week 4, week 8]
|
|
Secondary ID(s)
|
|
CTBM100CDE02
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|