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

Novartis

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Drug: Tobramycin solution for inhalation; Drug: Aztreonam lysine for inhalation

Study type: Observational

Funder types: Industry

Identifiers

NCT01460836

HEORUS0017

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Tobramycin Solution

Treatment:

Drug: Tobramycin solution for inhalation

Aztreonam lysine

Treatment:

Drug: Aztreonam lysine for inhalation