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
|
|
|
Aztreonam lysine
|
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
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.