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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014