NCT01460836

Brief Summary

Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.

Trial Health

100
On Track

Trial Health Score

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

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.1 years 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

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

October 25, 2011

Last Update Submit

October 26, 2011

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline

    Baseline, Weeks 2, 4 and 6

Secondary Outcomes (1)

  • Mean change in the density of Pseudomonas aeruginosa (PA) from baseline

    Baseline, Weeks 2, 4 and 6

Study Arms (2)

Tobramycin Solution

Drug: Tobramycin solution for inhalation

Aztreonam lysine

Drug: Aztreonam lysine for inhalation

Interventions

Tobramycin solution for inhalationDRUG
Tobramycin Solution
Aztreonam lysine for inhalationDRUG
Aztreonam lysine

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,
  • the ability to perform reproducible pulmonary function tests,
  • Pseudomonas aeruginosa (PA) airway infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Inhalation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Last Updated

October 27, 2011

Record last verified: 2011-10