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Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Tobramycin solution for inhalation (Drug); Aztreonam lysine for inhalation (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

Official title: Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

Study design: Time Perspective: Retrospective

Primary outcome: Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline

Secondary outcome: Mean change in the density of Pseudomonas aeruginosa (PA) from baseline

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥ 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.

Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: April 2010
Last updated: October 26, 2011

Page last updated: August 23, 2015

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