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

Sponsor
Chiesi Farmaceutici S.p.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01116089
Collaborator
(none)
25
Enrollment
5
Locations
2
Arms
15
Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bramitob® administered by PARI LC® PLUS nebulizer
  • Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Bramitob®, Tobrineb®,Actitob®

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results [day1-day28]

    5. Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL [on day 28]

    6. Time necessary for the nebulization of the dose [on day 1 and on day 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital Brno Bohunice Brno Czechia 625 00
    2 SMSI Institude of Cardiology Chisinau Moldova, Republic of MD-2025
    3 University hospital with Health Center Banská Bystrica Slovakia 975 17
    4 Fakultná nemocnica s poliklinikou Bratislava (FNsP) Brastislava Slovakia 826 06
    5 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chiesi Farmaceutici S.p.A.
    ClinicalTrials.gov Identifier:
    NCT01116089
    Other Study ID Numbers:
    • CCD-0908-PR-0029
    • 2009-016780-11
    First Posted:
    May 4, 2010
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jul 1, 2020
    Keywords provided by Chiesi Farmaceutici S.p.A.
    Cystic fibrosis, tobramycin,nebulizer, PK
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Jul 31, 2020