Bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa (PA) infection
| ISRCTN | ISRCTN85410458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85410458 |
| Secondary identifying numbers | 12012.101 |
- Submission date
- 03/02/2011
- Registration date
- 12/04/2011
- Last edited
- 29/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dorota Sands
Scientific
Scientific
Instytut Matki i Dziecka
ul.Kasprzaka 17a
Warszawa
01-211
Poland
Study information
| Study design | Comparative randomised two period multi-centre cross-over bioequivalence study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | T100 |
| Study objectives | 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(s) | Bioethics Committee of the Institute of Mother and Child in Warsaw, 21/01/2011, ref: 05/2011 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tobramycin |
| Primary outcome measure | 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 study start date | 15/03/2011 |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 15/03/2011 |
| Date of final enrolment | 30/08/2011 |
Locations
Countries of recruitment
- Poland
Study participating centre
Instytut Matki i Dziecka
Warszawa
01-211
Poland
01-211
Poland
Sponsor information
PARI Pharma GmbH (Germany)
Industry
Industry
Lochhamer Schlag 21
Graefelfing
82166
Germany
| info@paripharma.com | |
"ROR" |
https://ror.org/011pcrd91 |
Funders
Funder type
Industry
PARI Pharma GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2014 | Yes | No |
