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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02248922
Other study ID # CTBM100CDE02
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date January 27, 2015
Est. completion date April 10, 2017

Study information

Verified date January 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


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 identified as main driver.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TIS or TIP
300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

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