Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/02/2011
Date assigned
12/04/2011
Last edited
29/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dorota Sands

ORCID ID

Contact details

Instytut Matki i Dziecka
ul.Kasprzaka 17a
Warszawa
01-211
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12012.101

Study information

Scientific title

A comparative, randomised, two period, multi-centre, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa (PA) infection

Acronym

T100

Study hypothesis

It is postulated that the pharmacokinetics of T100 170 mg delivered with the Pari eFlow® after 4 weeks treatment is bioequivalent with the pharmacokinetics of TOBI® 300 mg delivered with the PARI LC® PLUS

Ethics approval

Bioethics Committee of the Institute of Mother and Child in Warsaw, 21/01/2011, ref: 05/2011

Study design

Comparative randomised two period multi-centre cross-over bioequivalence study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa infection

Intervention

Each patient will be randomised in a (1:1) ratio to receive either 2 x 170 mg/day T100/ Pari eFlow® or 2 x 300 mg/day TOBI®/PARI LC® PLUS.

After treatment phase 1 all patients switch to the conversed treatment group. Each treatment phase will last for 28 days.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tobramycin

Primary outcome measures

Comparison of mean plasma tobramycin AUC (0-12h) of T100 170 mg nebulised via Pari eFlow® and the registered TOBI® 300 mg nebulised via PARI LC® PLUS

Secondary outcome measures

Comparison of tobramycin peak plasma levels (Cmax plasma) of T100 nebulised via Pari eFlow® and the registered TOBI® nebulised via PARI LC® PLUS

Overall trial start date

15/03/2011

Overall trial end date

30/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed by patient (or appropriate legal representative) the written informed consent including data protection agreement after the nature of the study has been fully explained prior to any screening procedure
2. Patient is a male or female and at least 4 years of age at the time of screening
3. Patient's diagnosis of cystic fibrosis (CF) was confirmed by one or more specific clinical features consistent with CF and elevated chloride concentration in the sweat is greater than 60 mEq/l (by quantitative pilocarpine iontophoresis test - QPIT)
4. Presence of disease associated CF transmembrane conductance regulator (CFTR)
mutations in both alleles
5. Patient has adequate pulmonary function at screening defined as:
5.1. Forced expiratory volume in one second (FEV1) between at least 25% and less or equal to 85% of normal predicted values for age, sex and height based on Knudson criteria and peripheral artery haemoglobin oxygen saturation (SaO2) of at least 88% at rest measured by pulse oximetry on room air
6. Patient has a positive culture for PA at screening (Visit 1)
6.1. Patient should have PA isolated from sputum only if patient do not have a known history of positive PA culture within the last 2 months
7. Patient is clinically stable at screening (no change in FEV1 greater than 20% within one month prior to screening visit)
8. Patient is able to comply with all protocol requirements (e.g. able to produce sputum and
perform pulmonary function tests)
9. Sexually active women of childbearing potential and sexually active men will use a highly effective method of contraception throughout the IMP treatment period
10. Females of childbearing potential have a negative serum pregnancy test (within 7 days before visit 2/randomisation)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Use of investigational medications within 30 days before study entry or during the trial
2. Inability to handle the study inhalers to inhale the test preparations
3. Patient has a known local or systemic hypersensitivity or adverse reaction to inhaled
aminoglycosides or systemic aminoglycosides
4. Administration of anti-pseudomonas aminoglycoside antibiotics are not allowed within 30 days before first administration of IMP. Macrolide are permitted, provided that they are taken as a maintenance therapy for at least 6 weeks before entering the trial. Other antibiotics are not allowed within 7 days before first administration of IMP
5. Patient with haemoptysis at any time within 4 weeks prior to screening (Visit 1)
6. FEV1 less than 25% predicted
7. Patient has a positive sputum or deep throat cough culture or bronchoalveolar lavage (BAL) with Burkholderia cepacia (B cepacia) at screening (visit 1) and/or a history of positive culture yielding B cepacia within 1 year prior to screening
8. Presence of allergic bronchopulmonary aspergillosis (ABPA)
9. Patient experienced severe respiratory infection within one month prior to screening (visit 1) which requires hospitalisation or treatment with intravenous (i.v.) antibiotics
10. Elevated serum creatinine greater than 1.2 mg/dl or blood urine nitrogen (BUN) 20 mg/dl or proteinuria of grade 2plus or greater
11. Significant liver disease -greater than 2x upper standard limits and no thrombocytopenia or clinical active disease
12. Patients with auditory or/and vestibular dysfunctions
13. Patient has a history of lung transplantation
14. Patient has a co-existing medical condition or abnormality that would compromise the
participant's safety or the quality of the study data, in the opinion of the investigator
15. Active drug and alcohol abuse or psychiatric disease

Recruitment start date

15/03/2011

Recruitment end date

30/08/2011

Locations

Countries of recruitment

Poland

Trial participating centre

Instytut Matki i Dziecka
Warszawa
01-211
Poland

Sponsor information

Organisation

PARI Pharma GmbH (Germany)

Sponsor details

Lochhamer Schlag 21
Graefelfing
82166
Germany
-
info@paripharma.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

PARI Pharma GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24836961

Publication citations

Additional files

Editorial Notes