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

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Aztreonam lysine for inhalation; Drug: Tobramycin solution for inhalation

• Registration Number: NCT01460836
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-10
• Status Verified: 2011-10
• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-26
• Last Update Submitted: 2011-10-26
• Study First Posted: 2011-10-27
• Last Update Posted: 2011-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aztreonam lysine	Aztreonam lysine for inhalation	-
Tobramycin Solution	Tobramycin solution for inhalation	-

Primary Outcome Measures

Name	Time	Method
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline	Baseline, Weeks 2, 4 and 6

Secondary Outcome Measures

Name	Time	Method
Mean change in the density of Pseudomonas aeruginosa (PA) from baseline	Baseline, Weeks 2, 4 and 6