Cystic FibrosisPhase 1NCT01116089
Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer
A Phase 1 study testing Bramitob® administered by PARI LC® PLUS nebulizer and Bramitob® administered by PARI eFlow® rapid electronic nebulizer in people with Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 5 sites in 3 countries.
Trial summary
The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Bramitob® administered by PARI LC® PLUS nebulizer and Bramitob® administered by PARI eFlow® rapid electronic nebulizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2010to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- Patients of either sex aged ≥ 18 years;
- Clinical diagnosis of cystic fibrosis (patients registered in the National Registry of cystic fibrosis or other documents, if applicable, depending on country legislation);
- Positive response (sweat chloride concentration ≥ 60 mmol/l) in the standard sweat test documented in the clinical records or sweat chloride concentration ≥ 40 mmol/l and at least two gene mutations consistent with CF documented in the clinical records;
- Chronic colonization of Pseudomonas aeruginosa
- FEV1 ≥ 35% of the predicted normal value calculated according to the recommendation of the Official Statement of the European Respiratory Society and American Thoracic Society
Main exclusion Criteria:
- Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
- Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
- Sputum culture containing Burkholderia cepacia;
- Received loop diuretics within 7 days before study drug administration;
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Slovakia3 sites
University hospital with Health Center
Banská Bystrica, 975 17
Fakultná nemocnica s poliklinikou Bratislava (FNsP)
Brastislava, 826 06
University Hospital of L. Pasteur, Pneumonology Department
Košice, 041 90
About this study
Official title: PHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA
The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa
- Conditions
- Cystic Fibrosis
- Being tested
- Bramitob® administered by PARI LC® PLUS nebulizer, Bramitob® administered by PARI eFlow® rapid electronic nebulizer
- Keywords
- Cystic fibrosis, tobramycin,nebulizer, PK
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bramitob® administered by PARI LC® PLUS nebulizerDrug
Also called Bramitob®, Tobrineb®, Actitob®
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
Bramitob® administered by PARI eFlow® rapid electronic nebulizerDrug
Also called Bramitob®, Tobrineb®,Actitob®
(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| PARI LC® PLUS nebulizer | Active comparator | Not described Receives: Drug: Bramitob® administered by PARI LC® PLUS nebulizer |
| PARI eFlow® rapid electronic nebulizer | Active comparator | Not described Receives: Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Measured: on day 28
Secondary outcomes (6)
Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Measured: on day 1
Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Measured: on day 1 and on day 28
Accumulation of tobramycin in plasma and sputum after repeated doses calculated as the ratio: AUC0-t DAY 28 / AUC0-t DAY 1 and Cmax DAY 28 / Cmax DAY 1
Measured: day 1 - day 28
Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results
Measured: day1-day28
Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL
Measured: on day 28
Time necessary for the nebulization of the dose
Measured: on day 1 and on day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jozef Ružička, MD, PhD, Principal investigator, Fakultná nemocnica s poliklinikou Bratislava, SlovakiaAndrej Somos, MD, Principal investigator, University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, SlovakiaJana Skřičková, MD, PhD, Principal investigator, University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech RepublicEva Beresova, M.D, Principal investigator, University hospital with Health Center, F.D. Roosevelta Banská Bystrica, L. Svoboda´s square 1, 975 17, Banská Bystrica, SlovakiaSvetlana Şciuca, M.D, PhD, Principal investigator, SMSI Institude of Cardiology, MD-2025, 29/1 Testimitanu str., Chisinau, Republic of Moldova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116089
- Sponsor's protocol ID
- CCD-0908-PR-0029
- Other IDs
- 2009-016780-11, 2009
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2010
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ruzicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow((R)) rapid and PARI LC Plus((R)) nebulisers in cystic fibrosis patients. Pulm Pharmacol Ther. 2013 Apr;26(2):249-55. doi: 10.1016/j.pupt.2012.12.002. Epub 2012 Dec 8.
PubMed 23232039
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA
- ClinicalTrials.gov ID
- NCT01116089
- Acronym / sponsor ID
- CCD-0908-PR-0029
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, tobramycin,nebulizer, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess pharmacokinetic and safety comparability of Bramitob® when administered for inhalation by using PARI eFlow® rapid electronic nebulizer vs PARI LC® PLUS nebulizer in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARI LC® PLUS nebulizer | Active comparator | Drug: Bramitob® administered by PARI LC® PLUS nebulizer |
| PARI eFlow® rapid electronic nebulizer | Active comparator | Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bramitob® administered by PARI LC® PLUS nebulizerAlso: Bramitob®, Tobrineb®, Actitob®(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days | Drug | PARI LC® PLUS nebulizer |
| Bramitob® administered by PARI eFlow® rapid electronic nebulizerAlso: Bramitob®, Tobrineb®,Actitob®(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days | Drug | PARI eFlow® rapid electronic nebulizer |
Primary outcome
Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 28
6 secondary outcomes
Plasma tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 1
Sputum tobramycin pharmacokinetic parameters (Cmax, tmax and AUC0-t) after inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer
Time frame: on day 1 and on day 28
Accumulation of tobramycin in plasma and sputum after repeated doses calculated as the ratio: AUC0-t DAY 28 / AUC0-t DAY 1 and Cmax DAY 28 / Cmax DAY 1
Time frame: day 1 - day 28
Safety assessed by adverse events, adverse drug reactions, incidence of bronchospasm, laboratory parameters, physical examination, body weight, vital signs results
Time frame: day1-day28
Number of patients with minimum plasma tobramycin levels Cmin > 2mcg/mL and maximum plasma tobramycin levels Cmax > 12 mcg/mL
Time frame: on day 28
Time necessary for the nebulization of the dose
Time frame: on day 1 and on day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 23232039Govoni M, Poli G, Acerbi D, Santoro D, Cicirello H, Annoni O, Ruzicka J. Pharmacokinetic and tolerability profiles of tobramycin nebuliser solution 300 mg/4 ml administered by PARI eFlow((R)) rapid and PARI LC Plus((R)) nebulisers in cystic fibrosis patients. Pulm Pharmacol Ther. 2013 Apr;26(2):249-55. doi: 10.1016/j.pupt.2012.12.002. Epub 2012 Dec 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jozef Ružička, MD, PhD principal investigator
Fakultná nemocnica s poliklinikou Bratislava, Slovakia
Andrej Somos, MD principal investigator
University Hospital of L. Pasteur, Pneumonology Department, Rastislavova 43, 041 90, Kosice, Slovakia
Jana Skřičková, MD, PhD principal investigator
University Hospital Brno Bohunice, Jihlavská 20, 625 00, Brno, Czech Republic
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bramitob® administered by PARI LC® PLUS nebulizer and Bramitob® administered by PARI eFlow® rapid electronic nebulizer in people with Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Slovakia, Czechia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma tobramycin pharmacokinetic parameters (Cmax and AUC0-t) after twice daily inhalation of Bramitob® using PARI eFlow® nebulizer vs PARI LC® PLUS nebulizer (time frame: on day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.