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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Bramitob® administered by PARI LC® PLUS nebulizer

Bramitob® administered by PARI eFlow® rapid electronic nebulizer

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, tobramycin,nebulizer, PK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

University Hospital Brno Bohunice
SMSI Institude of Cardiology
University hospital with Health Center
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
University Hospital of L. Pasteur, Pneumonology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PARI LC® PLUS nebulizer

PARI eFlow® rapid electronic nebulizer

Arm Description

Outcomes

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

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

Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer

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

Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results

Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL

Time necessary for the nebulization of the dose

Full Information

NCT ID

NCT01116089

First Posted

April 29, 2010

Last Updated

July 30, 2020

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01116089

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic fibrosis, tobramycin,nebulizer, PK

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PARI LC® PLUS nebulizer

Arm Type

Active Comparator

Arm Title

PARI eFlow® rapid electronic nebulizer

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bramitob® administered by PARI LC® PLUS nebulizer

Other Intervention Name(s)

Bramitob®, Tobrineb®, Actitob®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bramitob® administered by PARI eFlow® rapid electronic nebulizer

Other Intervention Name(s)

Bramitob®, Tobrineb®,Actitob®

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results

Time Frame

day1-day28

Title

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

Title

Time necessary for the nebulization of the dose

Time Frame

on day 1 and on day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials: