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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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12 December 2020 |
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Main ID: |
NCT01116089 |
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Date of registration:
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29/04/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
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Scientific title:
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PHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01116089 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Czech Republic
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Czechia
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Moldova, Republic of
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Russian Federation
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Slovakia
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Contacts
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Name:
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Eva Beresova, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia |
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Name:
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Jana Skricková, MD, PhD |
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Address:
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Email:
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Affiliation:
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University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic |
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Name:
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Andrej Somos, MD |
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Address:
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Email:
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Affiliation:
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University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia |
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Name:
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Jozef Ružicka, MD, PhD |
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Address:
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Email:
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Affiliation:
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Fakultná nemocnica s poliklinikou Bratislava, Slovakia |
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Name:
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Svetlana Sciuca, M.D, PhD |
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Address:
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Email:
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Affiliation:
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SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova |
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Key inclusion & exclusion criteria
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Main inclusion Criteria:
- Patients of either sex aged = 18 years;
- Clinical diagnosis of cystic fibrosis (patients registered in the National Registry of
cystic fibrosis or other documents, if applicable, depending on country legislation);
- Positive response (sweat chloride concentration = 60 mmol/l) in the standard sweat
test documented in the clinical records or sweat chloride concentration = 40 mmol/l
and at least two gene mutations consistent with CF documented in the clinical records;
- Chronic colonization of Pseudomonas aeruginosa
- FEV1 = 35% of the predicted normal value calculated according to the recommendation of
the Official Statement of the European Respiratory Society and American Thoracic
Society
Main exclusion Criteria:
- Evidence of impaired renal function (serum creatinine level = 1.5 mg/dl);
- Evidence of impaired auditory function (auditory threshold in either ear above 20 dB
at frequencies between 250 and 8000Hz);
- Sputum culture containing Burkholderia cepacia;
- Received loop diuretics within 7 days before study drug administration;
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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: Bramitob® administered by PARI LC® PLUS nebulizer
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Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
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Primary Outcome(s)
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Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
[Time Frame: on day 28]
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Secondary Outcome(s)
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Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
[Time Frame: on day 1]
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Accumulation of tobramycin in plasma and sputum after repeated doses calculated as the ratio: AUC0-t DAY 28 / AUC0-t DAY 1 and Cmax DAY 28 / Cmax DAY 1
[Time Frame: day 1 - day 28]
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Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results
[Time Frame: day1-day28]
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Time necessary for the nebulization of the dose
[Time Frame: on day 1 and on day 28]
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Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL
[Time Frame: on day 28]
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Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
[Time Frame: on day 1 and on day 28]
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Secondary ID(s)
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2009-016780-11
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CCD-0908-PR-0029
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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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