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

NCT01116089 | Completed Phase 1

• 2 other identifiers: CCD-0908-PR-00292009-016780-11
• Study Type: interventional
• Target: 25
• Locations: 3 countries
• Sites: 5

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

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis, tobramycin,nebulizer, PK

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (2)

PARI LC® PLUS nebulizer

ACTIVE COMPARATOR

Drug: Bramitob® administered by PARI LC® PLUS nebulizer

PARI eFlow® rapid electronic nebulizer

ACTIVE COMPARATOR

Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer

Interventions

Bramitob® administered by PARI LC® PLUS nebulizer DRUG

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

Also known as: Bramitob®, Tobrineb®, Actitob®

PARI LC® PLUS nebulizer

Bramitob® administered by PARI eFlow® rapid electronic nebulizer DRUG

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

Also known as: Bramitob®, Tobrineb®,Actitob®

PARI eFlow® rapid electronic nebulizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (5)

University Hospital Brno Bohunice

Brno, 625 00, Czechia

Location

SMSI Institude of Cardiology

Chisinau, MD-2025, Moldova

Location

University hospital with Health Center

Banská Bystrica, 975 17, Slovakia

Location

Fakultná nemocnica s poliklinikou Bratislava (FNsP)

Brastislava, 826 06, Slovakia

Location

University Hospital of L. Pasteur, Pneumonology Department

Košice, 041 90, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 23232039 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 4, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

SL (3); MO (1); CZ (1)