Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections

• Conditions: Cystic Fibrosis with Pseudomoas aeuriginosa infection; MedDRA version: 8.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2005-004103-10-DE
• Lead Sponsor: PARI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patients older than 8 years of age.
- Subjects with documented CF: Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for AF508 genetic mutation (or heterozygosity for two well characterized mutations) and two clinical findings consistent with CF.
- Ability to perform reproducible spirometry.
- Stable condition with no exacerbation requiring IV antibiotics or hospitalization within one months period prior to screening visit.
- No change in FEV1 bigger than 20% from baseline within one month period prior to screening visit.
- Documented P. aeruginosa presence in a sputum/throat culture within 6 months prior to screening or at least two consecutive positive P. aeruginosa cultures within one year.
- FEV1 at least of 40% of predicted, based on gender, age and height.
- Room air oximetry from at least 88% saturation.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Use of an investigational drug within 30 days prior to study entry or during the trial.
2. Active drug and alcohol abuse.
3. Inability to handle the study inhalers or to inhale the test formulations.
4. Inability to adhere to the requirements of the protocol.
5. FEV1 lesst han 40% predicted.
6. Administration of any anti pseudomonas antibiotics by any route within 7 days prior to initial study drug administration, with the exception of macrolide, provided that these are taken as a maintenace therapy at least 6 weeks before entering the trial.
7. Severe respiratory infection within one month prior to screening, which requires hospital admission or treatment with intravenous antiobiotics
8. Positive urine pregnancy test.
9. Hemoptysis > 60 cc at any time within thirty days prior to study drug administration.
10. Known local or systemic hypersensitivity to aminoglycosides.
11. Serum creatinine = or greater than 1,2 mg/d, BUN = 20 mg/dl or greater, or an abnormal urine analysis defined as more than 1+ proteinuria in urinstix.
12.History of sputum culture or throat swab culture yielding B.cepacia in the
previous 12 months and/or sputum or throat swab culture yielding B. cepacia at
screening.
13. Presence of allergic bronchopulmonary aspergillosis (ABPA) as evidenced by
positive cultures for aspergillosis, positive skin test and IgE>1000 IU.
14. Patients with right side heart failure.
15. Non-compliance with recommended pulmonary rehabilitation
16. Significant liver disease clinically diagnosed.
17. Patients with history of GI bleeding.
18. Patients with known or suspected neuromuscular dysfunction.
19. Patients with known or suspected auditory or vestibular dysfunction.
20. Women of childbearing potential and sexually active who are not already using a high effective method of contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified