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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01116089
First received: April 29, 2010
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Cystic Fibrosis
Drug: Bramitob® administered by PARI LC® PLUS nebulizer
Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results [ Time Frame: day1-day28 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Time necessary for the nebulization of the dose [ Time Frame: on day 1 and on day 28 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PARI LC® PLUS nebulizer Drug: Bramitob® administered by PARI LC® PLUS nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Other Name: Bramitob®, Tobrineb®, Actitob®
Active Comparator: PARI eFlow® rapid electronic nebulizer Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Other Name: Bramitob®, Tobrineb®,Actitob®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116089

Locations
Czech Republic
University Hospital Brno Bohunice
Brno, Czech Republic, 625 00
Moldova, Republic of
SMSI Institude of Cardiology
Chisinau, Moldova, Republic of, MD-2025
Slovakia
University hospital with Health Center
Banská Bystrica, Slovakia, 975 17
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
Brastislava, Slovakia, 826 06
University Hospital of L. Pasteur, Pneumonology Department
Kosice, Slovakia, 041 90
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Jozef Ružička, MD, PhD Fakultná nemocnica s poliklinikou Bratislava, Slovakia
Principal Investigator: Andrej Somos, MD University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia
Principal Investigator: Jana Skřičková, MD, PhD University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic
Principal Investigator: Eva Beresova, M.D University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, Slovakia
Principal Investigator: Svetlana Şciuca, M.D, PhD SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01116089     History of Changes
Other Study ID Numbers: CCD-0908-PR-0029, 2009-016780-11
Study First Received: April 29, 2010
Last Updated: November 16, 2011
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Chiesi Farmaceutici S.p.A.:
Cystic fibrosis, tobramycin,nebulizer, PK

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014