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Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer

NCT01116089 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-07-31

No results posted yet for this study

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

Conditions

Interventions

DRUG

Bramitob® administered by PARI LC® PLUS nebulizer

(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days

DRUG

Bramitob® administered by PARI eFlow® rapid electronic nebulizer

(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jozef Ružička, MD, PhD · Fakultná nemocnica s poliklinikou Bratislava, Slovakia

  • Andrej Somos, MD · University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia

  • Jana Skřičková, MD, PhD · University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic

  • Eva Beresova, M.D · University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia

  • Svetlana Şciuca, M.D, PhD · SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Czechia
  • Moldova
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116089 on ClinicalTrials.gov