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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. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2009-016590-15-FR |
Date of registration:
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14/12/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. |
Date of first enrolment:
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15/04/2010 |
Target sample size:
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72 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016590-15 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: yes Other trial design description: negative Pa culture at day 29. Open label active if Pa positive culture If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Greece
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Hungary
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Italy
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Poland
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent given by the parent/legal guardian on behalf of the subject. 2. Diagnosis of CF by one or more clinical features of CF: • a documented sweat chloride test of > 60 mEq/L by quantitative pilocarpine iontophoresis • genotype with two identifiable CF-causing mutations • a positive newborn screening for CF 3. Male and female subjects aged 3 months to less than 7 years of age at the time of screening. 4. Early lower respiratory tract infection with P. aeruginosa, defined by either of the following: • infection defined as the first time P. aeruginosa is isolated from sputum or deep throat cough swab culture, or • isolation of P. aeruginosa from sputum or deep-throat cough-swab culture after at least 1 year of negative cultures (documented with at least two negative cultures during the latter 1-year period, with no positive culture during that period), no antipseudomonal treatment by any route of administration during this one-year period; 5. Able to comply with all protocol requirements (except spirometry where not applicable) 6. Clinically stable in the opinion of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Serum creatinine above the upper limit of the normal range for age. 2. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. 3. Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax. 4. Administration of any investigational drug within 30 days or 5 half-lives prior to enrollment, whichever is longer. 5. Administration of loop diuretics within 7 days prior to study drug administration. 6. Personal/family history of abnormal hearing 7. Current (continuing, present at screening) or persisting abnormal result from audiology testing (as defined in protocol). 8. History of sputum culture, throat swab, or lower respiratory specimen culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening. 9. Hemoptysis which is clinically significant based on the subjects age and clinical status within 30 days prior to study drug administration. 10. History of malignancy of any organ system treated or untreated, regardless of whether there is evidence of local recurrence or metastases, 11. Subjects with clinically significant laboratory abnormalities including congenital diseases other than CF (not associated with the study indication) at screening, 12. Subjects with other clinically significant conditions (not associated with the study indication) at screening which might interfere with the assessment of this study 13. Subjects or caregivers with a history of noncompliance to medical regimens and subjects or caregivers who are considered potentially unreliable.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0
Level: LLT
Classification code 10068297
Term: Pseudomonas colonisation
MedDRA version: 12.0
Level: LLT
Classification code 10068292
Term: Pseudomonas colonization
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Intervention(s)
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Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use
Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60-
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Primary Outcome(s)
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Primary end point(s): Proportion of patients with negative P. aeruginosa culture at day 29 in each treatment group
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Secondary Objective: • To assess the safety profile of TOBI inhaled twice daily or placebo throughout the treatment period in subjects in this age group. • To estimate the proportion of subjects free from any strain of P. aeruginosa assessed by sputum / swab culture 28 days after termination of the 2nd treatment cycle (day 91) with either TOBI inhaled twice daily for 28 days or placebo. • To estimate the proportion of subjects free from any strain of P. aeruginosa assessed by sputum / swab culture 28 days after termination of treatment with either TOBI inhaled twice daily for 28 days or placebo. • To assess the pharmacokinetics of TOBI in this age group • To assess lung function in the subset of subjects able to reliably perform spirometry See exploratory objectives into the protocol page 16.
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Main Objective: To estimate the proportion of subjects free from any strain of P. aeruginosa assessed by sputum / swab culture at Day 29, i.e. after completion of a 28-day treatment period with either TOBI or placebo solution inhaled twice daily.
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Secondary ID(s)
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CTBM100C2304
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2009-016590-15-HU
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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