NCT01460849

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
Last Updated

December 7, 2021

Status Verified

November 1, 2021

Enrollment Period

Same day

First QC Date

October 25, 2011

Last Update Submit

November 23, 2021

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Mortality

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cystic fibrosis

You may qualify if:

  • ≥6 years of age with a documented Cystic fibrosis (CF) diagnosis,
  • moderate-to-severe lung disease,
  • Pseudomonas aeruginosa (PA) airway infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

December 7, 2021

Record last verified: 2021-11