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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01460836 |
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Date of registration:
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25/10/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
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Scientific title:
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Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01460836 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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Phase:
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N/A
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Tobramycin solution for inhalation
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Drug: Aztreonam lysine for inhalation
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Primary Outcome(s)
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Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
[Time Frame: Baseline, Weeks 2, 4 and 6]
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Secondary Outcome(s)
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Mean change in the density of Pseudomonas aeruginosa (PA) from baseline
[Time Frame: Baseline, Weeks 2, 4 and 6]
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Secondary ID(s)
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HEORUS0017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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