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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116089
• Other study ID #: CCD-0908-PR-0029
• Secondary ID: 2009-016780-11
• Status: Completed
• Phase: Phase 1
• Start date: July 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Bramitob® administered by PARI LC® PLUS nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
• Bramitob® administered by PARI eFlow® rapid electronic nebulizer
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days

Locations

Country	Name	City	State
Czechia	University Hospital Brno Bohunice	Brno
Moldova, Republic of	SMSI Institude of Cardiology	Chisinau
Slovakia	University hospital with Health Center	Banská Bystrica
Slovakia	Fakultná nemocnica s poliklinikou Bratislava (FNsP)	Brastislava
Slovakia	University Hospital of L. Pasteur, Pneumonology Department	Kosice

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Czechia,  Moldova, Republic of,  Slovakia, 

References & Publications (1)

Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ružicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow(®) rapid and PARI LC Plus(®) nebulisers in cystic fibrosis patients. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results		day1-day28
Secondary	Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL		on day 28
Secondary	Time necessary for the nebulization of the dose		on day 1 and on day 28