A Phase 4 interventional study of TIS or TIP in Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis, sponsored by Novartis Pharmaceuticals. Terminated at 6 sites in Germany. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Diagnostic
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.
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.
97 studies on the registry are indexed under Pseudomonas Infections; 23 are open to participants now.
This study's enrollment of 17 is below the median of 56 across 60 interventional studies indexed under Pseudomonas Infections.
Browse Pseudomonas Infections studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)twice a day (BID) 28days on / 28 days off
Drug: TIS or TIP
300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)
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.
Time frame: Baseline, week 4
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
Time frame: Baseline, week 4
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.
Time frame: Baseline, week 4
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.
Time frame: Baseline, week 1
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.
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)
Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry
Time frame: week 4, week 8
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.
Time frame: week 4, week 8
At least 35 patients were planned to be recruited in the study. However, in total, 17 patients entered into the study and completed. Reason for termination was challenge with enrollment and recruitment. A significant decrease in the eligible patient population was main driver.
| Milestone | Tobramycin Inhalation Solution(TIS) | Tobramycin Inhalation Powder (TIP) |
|---|---|---|
| Started | 5 | 12 |
| Completed | 5 | 12 |
| Not completed | 0 | 0 |
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.
| units on a scale | Tobramycin ALL |
|---|---|
| Baseline | 17.985 ± 1.1494 |
| Week 4 | 17.101 ± 0.8409 |
Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry
| % predicted | Tobramycin ALL |
|---|---|
| Baseline | 76.964 ± 4.5121 |
| Week 4 | 77.481 ± 4.9877 |
Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum.
| CFU per gram sputum | Tobramycin ALL |
|---|---|
| Baseline | 56594.3 ± 28018.89 |
| Week 4 | 26113.0 ± 27280.98 |
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.
| units on a scale | Tobramycin ALL |
|---|---|
| Baseline | 17.985 ± 1.1494 |
| Week 1 | 17.506 ± 1.0002 |
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.
| Units on a scale | Tobramycin ALL |
|---|---|
| Week 4 | 17.101 ± 0.8409 |
| Week 8 | 16.489 ± 1.1473 |
Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry
| % predicted | Tobramycin ALL |
|---|---|
| Week 4 | 77.481 ± 4.9877 |
| Week 8 | 78.705 ± 5.4782 |
Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum.
| CFU per gram sputum | Tobramycin ALL |
|---|---|
| Week 4 | 26113.0 ± 27280.98 |
| Week 8 | 56285.0 ± 28022.28 |
Collected over Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment through study completion, an average of 11 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tobramycin Inhalation Solution(TIS) | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Tobramycin Inhalation Powder (TIP) | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Tobramycin Inhalation Solution(TIS) | Tobramycin Inhalation Powder (TIP) |
|---|---|---|
| SunburnInjury, poisoning and procedural complications | 1/5 | 0/12 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 1/5 | 0/12 |
| Abdominal pain upperGastrointestinal disorders | 0/5 | 1/12 |
| Forced expiratory volume decreasedInvestigations | 0/5 | 1/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/5 | 1/12 |
| Obstructive airways disorderRespiratory, thoracic and mediastinal disorders | 0/5 | 1/12 |
| Age, Continuous(years) | Tobramycin Inhalation Solution(TIS) | Tobramycin Inhalation Powder (TIP) | Total |
|---|---|---|---|
| Mean | 20.2 ± 8.26 | 28.9 ± 9.79 | 26.4 ± 9.99 |
| Sex: Female, Male(Participants) | Tobramycin Inhalation Solution(TIS) | Tobramycin Inhalation Powder (TIP) | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 2 | 9 | 11 |
| Race (NIH/OMB)(Participants) | Tobramycin Inhalation Solution(TIS) | Tobramycin Inhalation Powder (TIP) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 12 | 17 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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