A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.

• Conditions: patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa; MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2007-004507-36-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-19
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male and female subjects aged =6 years at the time of screening, with an Informed Consent Form signed by patient and if appropriate by parent/legal guardians, prior to any study-related procedure.
2.Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L; or identification of well-characterized disease-causing mutations in each CFTR gene; or an abnormal nasal transepithelial potential difference characteristic of CF.
3.P. aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage [BAL]) at the screening visit and within 6 months prior to screening.

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.History of sputum (or BAL) culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
2.FEV1 <25% of normal predicted values for age, sex, and height based on Knudson criteria at screening [Knudson 1983; criteria programmed into the spirometers].
3.Hemoptysis of more than 60 cc at any time within 30 days prior to study drug administration.
4.Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
5.GFR<60ml/min/1.73m2 calculated with the Formula by Schwartz [Lhotta 2005, see Appendix 3], BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
6.History of tinnitus or pathologic audiometry that might conceal a worsening of hearing
7.diagnosis of acute or subacute allergic bronchopulmonary aspergillosis (ABPA) as defined by the Consensus Conference on Diagnostic and Screening Criteria for ABPA in CF (Classic case) at screening
8.Initiation of treatment with macrolide antibiotics within 28 days prior to study drug administration (subjects may be taking macrolide antibiotics at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration).
9.Use of loop diuretics within 7 days prior to study drug administration.
10.Initiation of treatment with dornase alpha within 28 days prior to study drug administration (subjects may be taking dornase alpha at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration).
11.Initiation of treatment with inhaled steroids or modification of dose within 28 days prior to study drug administration (subjects may be taking inhaled steroids at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration).
12.Unable to comply with all protocol requirements.
13.Clinically unstable in the opinion of the investigator.
14.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
15.History of hypersensitivity to the study drug or to drugs with similar chemical structures
16.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
17.Women
owho are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
owho are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion
[*definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
**examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe:
-Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
-Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr

Study & Design

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