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

Novartis Pharmaceuticals

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Cystic Fibrosis

Interventions

Tobramycin solution for inhalationDRUG

Aztreonam lysine for inhalationDRUG

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Baseline, Weeks 2, 4 and 6

Secondary Outcomes

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

Time frame: Baseline, Weeks 2, 4 and 6

Data from ClinicalTrials.gov

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