Phase 4
N=157
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
Pulmonary Infections · Pseudomonas Aeruginosa in Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01519661 ↗Enrolled (actual)
157
Serious AEs
31.2%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths — 85.4; 31.2; 0.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TBM100 (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths |
85.4; 31.2; 0.0 | — |
| SECONDARY Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted |
0.8; 0.0; 0.2; -0.2; -1.5; -1.9 | — |
| SECONDARY Relative Change From Baseline in FVC Percent Predicted |
-2.5; -2.8; -2.1; -1.8; -3.5; -3.1 | — |
| SECONDARY Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted |
10.3; 9.4; 5.5; 6.0; 2.9; 4.3 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum |
-1.6; -1.1; -1.2; -1.1; -1.3; -1.2 | — |
| SECONDARY Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa |
2; 2; 2; 2; 2; 2 | — |
| SECONDARY Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events |
26.8 | — |
| SECONDARY Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events |
18.1 | — |
| SECONDARY Time to First Hospitalization Due to Serious Respiratory-related Adverse Events |
NA | — |
| SECONDARY Percentage of Participants Who Used New Anti-pseudomonal Antibiotics |
65.6 | — |
| SECONDARY Number of Days of New Anti-pseudomonal Antibiotic Use |
33.1 | — |
| SECONDARY Time to Use of New Anti-pseudomonal Antibiotic |
136 | — |
Summary
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of Cystic Fibrosis
- FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
- Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening
Exclusion Criteria
- History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
- Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
- History of hearing loss or chronic tinnitus deemed clinically significant
- Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
- Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
- Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
- Use of loop diuretics within 7 days prior to study drug administration
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01519661). 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.