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

Phase 1

• Conditions: Cystic Fibrosis with Pseudomonas aeruginosa infections; MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-26
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Signed Informed Consent before the screening visit examinations.
- Patients older 8 years of age.
- Subjects with 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.
- Sexually active females of childbearing potential will be included only if they already use for other reasons a highly effective contraceptive method prior study initiation.
- Ability to perform reproducible spirometry.
- FEV1 lower then 40 % of predicted, based on gender, age and height.
- No change in FEV1 more than 20% within one month period prior to screening visit.
- Stable condition with no exacerbation requiring IV antibiotics or hospitalization 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.
- Resting oxygen saturation with pulse oximetry at least 88% on room air.
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

- Use of investigational medications within 30 days before study entry or during the trial.
- Active drug and alcohol abuse.
- Inability to handle the study inhalers or to inhale the test formulations.
- Inability to adhere to the requirements of the protocol.
- FEV1 < 40% predicted.
- Administration of any anti-pseudomonas antibiotics (with the exception of macrolide) by any route within 7 days prior to initial study drug administration.
- Positive urine pregnancy test. Test must be performed at screening.
- Severe respiratory infection within one month prior to screening, which requires hospital admission or treatment with intravenous antibiotics.
- Active, severe Hemoptysis, defined as Hemoptysis > 60 cc at any time within thirty days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides.
- Elevated serum creatinine > 1, 2 mg/dl or BUN equal 20 mg/dl, or an abnormal urine analysis defined as having more than + proteinuria in urinstix.
- 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.
- Presence of allergic bronchopulmonary aspergillosis (ABPA).
- Significant liver disease (> 2x Upper Standard limits and no thrombocytopenia or clinical liver disease).
- Patients with history of GI bleeding.
- Patients with auditory or/and vestibular dysfunctions.
- Patients with neuromuscular diseases.
- 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