Trial | NCT01116089  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tobramycin ...

  • Study Participants

    25
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
Study Started
Jul 31
2010
Primary Completion
Oct 31
2011
Study Completion
Oct 31
2011
Last Update
Jul 31
2020

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®

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®

PARI LC® PLUS nebulizer Active Comparator

PARI eFlow® rapid electronic nebulizer Active Comparator

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;
No Results Posted