ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01460836
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : October 27, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Drug: Tobramycin solution for inhalation Drug: Aztreonam lysine for inhalation

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Time Perspective: Retrospective
Official Title: Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
Study Start Date : April 2010
Actual Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Mean change in the density of Pseudomonas aeruginosa (PA) from baseline [ Time Frame: Baseline, Weeks 2, 4 and 6 ]

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic fibrosis
Criteria

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.

Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460836


Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01460836     History of Changes
Other Study ID Numbers: HEORUS0017
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cystic fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Respiratory Aspiration
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Respiration Disorders
Pharmaceutical Solutions
Tobramycin
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents