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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobramycin Solution for Inhalation

Drug

Aztreonam lysine for inhalation

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
First posted: Oct 27, 2011
Registry last updated: Oct 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed