Clinical trial NCT01116089: Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis, tobramycin,nebulizer, PK
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa


Eligibility criteria: 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;

Primary outcomes:
measure: Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
timeFrame: on day 28
Secondary outcomes:
measure: Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
timeFrame: on day 1
measure: Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
timeFrame: on day 1 and on day 28
measure: 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
timeFrame: day 1 - day 28
measure: Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results
timeFrame: day1-day28
measure: Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL
timeFrame: on day 28
measure: Time necessary for the nebulization of the dose
timeFrame: on day 1 and on day 28
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno Bohunice
city: Chisinau
country: Moldova, Republic of
facility: SMSI Institude of Cardiology
city: Banská Bystrica
country: Slovakia
facility: University hospital with Health Center
city: Brastislava
country: Slovakia
facility: Fakultná nemocnica s poliklinikou Bratislava (FNsP)
city: Kosice
country: Slovakia
facility: University Hospital of L. Pasteur, Pneumonology Department
Study officials:
affiliation: Fakultná nemocnica s poliklinikou Bratislava, Slovakia
name: Jozef Ružička, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia
name: Andrej Somos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic
name: Jana Skřičková, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia
name: Eva Beresova, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova
name: Svetlana Şciuca, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ruzicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow((R)) rapid and PARI LC Plus((R)) nebulisers in cystic fibrosis patients. Pulm Pharmacol Ther. 2013 Apr;26(2):249-55. doi: 10.1016/j.pupt.2012.12.002. Epub 2012 Dec 8.