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
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