Phase 4
Completed N=45
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
Long-term Safety of TIP
Source: ClinicalTrials.gov NCT01775137 ↗
Enrolled (actual)
45
Serious AEs
34.8%
Results posted
Nov 2015
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles — 39; 10; 18; 11 Participants
Summary
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles |
39; 10; 18; 11; 19; 2 | — |
| SECONDARY Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles |
5.0; 0.8; 1.3; 0.0; -0.5; -1.6 | — |
| SECONDARY Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles |
-1.9; -1.5; -1.4; -1.2; -2.2; -1.4 | — |
| SECONDARY Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles |
2; 2; 2; 2; 2; 2 | — |
| SECONDARY Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles |
77.8 | — |
| SECONDARY Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles |
59.0; 42.0; 32.0; 9.0 | — |
| SECONDARY Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles |
202.0 | — |
| SECONDARY The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study. |
40.0 | — |
| SECONDARY Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles |
17.0 | — |
| SECONDARY Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles |
NA | — |
| SECONDARY Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles |
-4.9; -3.5; -3.5; -2.6; -3.2; -3.8 | — |
| SECONDARY Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study |
4.0; 2.4; 2.4; -1.4; 0.3; -0.6 | — |
| SECONDARY Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study |
-0.7; -0.2; -0.2; 0.2; 0.0; 0.4 | — |
| SECONDARY Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study |
68.9 | — |
| SECONDARY Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study |
33.0; 28.0; 16.0; 9.0 | — |
| SECONDARY Time to Use of New Anti-pseudomonal Antibiotics in Extension Study |
139 | — |
| SECONDARY Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study |
35.6 | — |
| SECONDARY Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study |
16.0 | — |
| SECONDARY Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study |
NA | — |
| SECONDARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study |
36; 16; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study
Exclusion Criteria
- Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
- Use of loop diuretics within 7 days prior to entry into the extension study
- Pregnant or nursing women
- Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
Data sourced from ClinicalTrials.gov (NCT01775137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.