Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Interventions
- Drug: Bramitob® administered by PARI LC® PLUS nebulizerDrug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
- Registration Number
- NCT01116089
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PARI LC® PLUS nebulizer Bramitob® administered by PARI LC® PLUS nebulizer - PARI eFlow® rapid electronic nebulizer Bramitob® administered by PARI eFlow® rapid electronic nebulizer -
- Primary Outcome Measures
Name Time Method Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer on day 28
- Secondary Outcome Measures
Name Time Method Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer on day 1 and on day 28 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 day 1 - day 28 Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results day1-day28 Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL on day 28 Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer on day 1 Time necessary for the nebulization of the dose on day 1 and on day 28
Trial Locations
- Locations (5)
SMSI Institude of Cardiology
🇲🇩Chisinau, Moldova, Republic of
University Hospital Brno Bohunice
🇨🇿Brno, Czechia
University Hospital of L. Pasteur, Pneumonology Department
🇸🇰Kosice, Slovakia
University hospital with Health Center
🇸🇰Banská Bystrica, Slovakia
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
🇸🇰Brastislava, Slovakia