Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers
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ClinicalTrials.gov Identifier: NCT01460849 |
Recruitment Status : Unknown
Verified November 2017 by Novartis ( Novartis Pharmaceuticals ).
Recruitment status was: Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : November 17, 2017
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Condition or disease |
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Cystic Fibrosis |
Study Type : | Observational |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Assess the Increased Mortality Risk With Each Year of Delayed TIS Initiation, and the Effect of TIS on Mortality Across Study Centers |
Study Start Date : | March 2011 |

- Time to tobramycin solution (TIS) initiation from first year of TIS eligibility
- Mortality

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- moderate-to-severe lung disease,
- Pseudomonas aeruginosa (PA) airway infection.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460849
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01460849 |
Other Study ID Numbers: |
HEORUS0088 |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | November 17, 2017 |
Last Verified: | November 2017 |
Cystic fibrosis |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |