Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT01460836 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : October 27, 2011
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Condition or disease | Intervention/treatment |
---|---|
Cystic Fibrosis | Drug: Tobramycin solution for inhalation Drug: Aztreonam lysine for inhalation |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Tobramycin Solution |
Drug: Tobramycin solution for inhalation |
Aztreonam lysine |
Drug: Aztreonam lysine for inhalation |
- Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline [ Time Frame: Baseline, Weeks 2, 4 and 6 ]
- Mean change in the density of Pseudomonas aeruginosa (PA) from baseline [ Time Frame: Baseline, Weeks 2, 4 and 6 ]

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01460836 |
Other Study ID Numbers: |
HEORUS0017 |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | October 27, 2011 |
Last Verified: | October 2011 |
Cystic fibrosis |
Cystic Fibrosis Respiratory Aspiration Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Respiration Disorders Tobramycin Aztreonam Anti-Bacterial Agents Anti-Infective Agents |