Assess Increased Mortality Risk With Each Year of Delayed Tobramycin Solution (TIS) Initiation, and Effect of TIS on Mortality Across Study Centers

Novartis

Status: Withdrawn

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01460849

HEORUS0088

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.