FindTrial
Sign In

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01460836
Enrollment
Unknown
Registered
2011-10-27
Start date
2010-04-30
Completion date
Unknown
Last updated
2011-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis

Brief 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.

Interventions

DRUGTobramycin solution for inhalation
DRUGAztreonam lysine for inhalation

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baselineBaseline, Weeks 2, 4 and 6

Secondary

MeasureTime frame
Mean change in the density of Pseudomonas aeruginosa (PA) from baselineBaseline, Weeks 2, 4 and 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026