Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
Study Identifier:
CCD-0908-PR-0029
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Cystic Fibrosis
Study Drug
- Drug: Bramitob® administered by PARI LC® PLUS nebulizer
- Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer
Date
Jul 2010 - Oct 2011
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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;
Healthy Volunteers
No
Protocol 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
Study Locations
Location
Status
Location
University Hospital Brno Bohunice
Brno, Czech Republic, 625 00
Status
N/A
Location
SMSI Institude of Cardiology
Chisinau, Republic of Moldova, MD-2025
Status
N/A
Location
University hospital with Health Center
Banská Bystrica, Slovakia, 975 17
Status
N/A
Location
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
Brastislava, Slovakia, 826 06
Status
N/A
Location
University Hospital of L. Pasteur, Pneumonology Department
Košice, Slovakia, 041 90
Status
N/A