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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 : Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
Using CFF registry data, this analysis will: describe patterns of time to TIS initiation from first year of TIS eligibility, estimate the increased risk of death attributable to each year of delayed TIS initiation, and investigate TIS effects across study centers.

Condition or disease
Cystic Fibrosis

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Time to tobramycin solution (TIS) initiation from first year of TIS eligibility

Secondary Outcome Measures :
  1. Mortality

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Cystic fibrosis
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01460849     History of Changes
Other Study ID Numbers: HEORUS0088
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cystic fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases