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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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16 December 2017 |
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Main ID: |
NCT01069705 |
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Date of registration:
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15/02/2010 |
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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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Second Open Label Extension to Bridging Study CTBM100C2303
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Scientific title:
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A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1. |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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49 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01069705 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Estonia
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Latvia
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Lithuania
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Romania
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Russian Federation
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South Africa
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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:
- Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study
CTBM100C2303E1 took place not more than 5 days before enrollment into this study
- Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection.
- FEV1 at screening (at start of study CTBM100C2303) must be between 25% and 80% of
normal predicted values.
Exclusion Criteria:
- Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial
CTMB100C2303E1 and the enrollment into this study.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Age minimum:
6 Years
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pseudomonas Aeruginosa
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Pulmonary Infections
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Intervention(s)
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Drug: Tobramycin inhalation powder
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Primary Outcome(s)
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Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis.
[Time Frame: Each visit during the 168-day treatment period]
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Secondary Outcome(s)
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Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.
[Time Frame: Each visit during the 168-day treatment period]
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Density of microorganisms in sputum samples
[Time Frame: Each visit during the 168-day treatment period]
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Secondary ID(s)
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CTBM100C2303E2
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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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