Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis Clinical Trial
— ELIXIROfficial 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
| Verified date | January 2018 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 forced expiratory volume at 1 second (FEV1) to measure effectiveness of antibiotic therapy in patients with CF aged 6 years and older with mild to moderate lung disease.
| Status | Terminated |
| Enrollment | 17 |
| Est. completion date | April 10, 2017 |
| Est. primary completion date | April 10, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Erlangen | |
| Germany | Novartis Investigative Site | Essen | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Germering | |
| Germany | Novartis Investigative Site | Jena |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Lung Clearance Index (LCI) After 4 Weeks Following Onset of Study | The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal. | Baseline, week 4 | |
| Secondary | Change From Baseline of Forced Expiratory Volume at 1 Second (FEV1) After 4 Weeks Following Onset of Study | Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry | Baseline, week 4 | |
| Secondary | Change From Baseline of Colony-forming Units (CFU) After 4 Weeks Following Onset of Study | Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum. | Baseline, week 4 | |
| Secondary | Change From Baseline in Lung Clearance Index (LCI) After 1 Week | The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal. | Baseline, week 1 | |
| Secondary | 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) | The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal. | week 4, week 8 | |
| Secondary | 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) | Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry | week 4, week 8 | |
| Secondary | 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) | Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum. | week 4, week 8 |