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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin Solution |
| ||
| Aztreonam lysine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin solution for inhalation | Drug |
| ||
| Aztreonam lysine for inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline | Baseline, Weeks 2, 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the density of Pseudomonas aeruginosa (PA) from baseline | Baseline, Weeks 2, 4 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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Cystic fibrosis
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| Drug |
|
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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