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

Chiesi

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Bramitob® administered by PARI LC® PLUS nebulizer

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01116089

2009-016780-11 (EudraCT Number)

CCD-0908-PR-0029

Details and patient eligibility

About

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

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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;