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

October 26, 2011 updated by: Novartis Pharmaceuticals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cystic fibrosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tobramycin Solution
Drug: Tobramycin solution for inhalation
Aztreonam lysine
Drug: Aztreonam lysine for inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
Time Frame: Baseline, Weeks 2, 4 and 6
Baseline, Weeks 2, 4 and 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in the density of Pseudomonas aeruginosa (PA) from baseline
Time Frame: Baseline, Weeks 2, 4 and 6
Baseline, Weeks 2, 4 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Estimate)

October 27, 2011

Last Update Submitted That Met QC Criteria

October 26, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEORUS0017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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