HealthyEarly Phase 1NCT02277808
Which Apparatus for Inhaled Pentamidine?
A Early Phase 1 study testing 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Respirgard II and Isoneb® in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Respirgard II and Isoneb®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Oct 2014
- Phase
- Early 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be in good health
Who cannot join
- Known Tachycardia
- Renal Dysfunction
- Respiratory Diseases and history
Trial locations and contacts
1 site in 1 country.
Nicolas Audag, PT contact
Belgium1 site, 1 recruiting
- Recruiting
Clinique universitaire Saint-Luc
Brussels
Gregory Reychler, PhD
Gregory Reychler, PhD
About this study
Official title: Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.
The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.
- Conditions
- Healthy
- Being tested
- 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Respirgard II, Isoneb®
- Keywords
- Pneumocystis, Nebulizer, Pentamidine
- Medical subject headings
- Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)Drug
Respirgard IIDevice
Isoneb®Device
| Study group | Role | What they receive |
|---|---|---|
| Respirgard II | Active comparator | Determination of pulmonary deposition Receives: Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%); Device: Respirgard II |
| Isoneb | Active comparator | Determination of pulmonary deposition Receives: Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%); Device: Isoneb® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amikacine urinary dosage
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Grégory Reychler, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277808
- Sponsor's protocol ID
- Nebulizers for pentamidine
- Status last verified
- Oct 2014
- First submitted
- 27 Oct 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Oudyi M, Chaumuzeau JP, Diot P, Dubus JC; GAT (Groupe Aerosoltherapie de la SPLF). [Use of pentamidine nebulization in children]. Rev Mal Respir. 2012 May;29(5):656-63. doi: 10.1016/j.rmr.2012.02.003. Epub 2012 Mar 28. French.
PubMed 22682591McIvor RA, Berger P, Pack LL, Rachlis A, Chan CK. An effectiveness community-based clinical trial of Respirgard II and Fisoneb nebulizers for Pneumocystis carinii prophylaxis with aerosol pentamidine in HIV-infected individuals. Toronto Aerosol Pentamidine Study (TAPS) Group. Chest. 1996 Jul;110(1):141-6. doi: 10.1378/chest.110.1.141.
PubMed 8681618Kim CS, Garcia L, Wanner A. Actual pentamidine dose delivered by Respigard II nebulizer. Eur Respir J. 1995 Dec;8(12):2178-81. doi: 10.1183/09031936.95.08122178.
PubMed 8666114
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.
- ClinicalTrials.gov ID
- NCT02277808
- Acronym / sponsor ID
- Nebulizers for pentamidine
- Conditions
- Healthy
- Keywords
- Pneumocystis, Nebulizer, Pentamidine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- First posted
- 29 Oct 2014 (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 reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respirgard II | Active comparator | Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Device: Respirgard IIDetermination of pulmonary deposition |
| Isoneb | Active comparator | Drug: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Device: Isoneb®Determination of pulmonary deposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Be in good health
Key exclusion criteria (3 listed)
- Known Tachycardia
- Renal Dysfunction
- Respiratory Diseases and history
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 |
|---|---|---|
| 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%) | Drug | Isoneb, Respirgard II |
| Respirgard II | Device | Respirgard II |
| Isoneb® | Device | Isoneb |
Primary outcome
Amikacine urinary dosage
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Background: PubMed 22682591Oudyi M, Chaumuzeau JP, Diot P, Dubus JC; GAT (Groupe Aerosoltherapie de la SPLF). [Use of pentamidine nebulization in children]. Rev Mal Respir. 2012 May;29(5):656-63. doi: 10.1016/j.rmr.2012.02.003. Epub 2012 Mar 28. French.
- Background: PubMed 8681618McIvor RA, Berger P, Pack LL, Rachlis A, Chan CK. An effectiveness community-based clinical trial of Respirgard II and Fisoneb nebulizers for Pneumocystis carinii prophylaxis with aerosol pentamidine in HIV-infected individuals. Toronto Aerosol Pentamidine Study (TAPS) Group. Chest. 1996 Jul;110(1):141-6. doi: 10.1378/chest.110.1.141.
- Background: PubMed 8666114Kim CS, Garcia L, Wanner A. Actual pentamidine dose delivered by Respigard II nebulizer. Eur Respir J. 1995 Dec;8(12):2178-81. doi: 10.1183/09031936.95.08122178.
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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.
Nicolas Audag, PT contact
Grégory Reychler, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%), Respirgard II and Isoneb® in people with Healthy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Audag, PT (nicolas.audag@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amikacine urinary dosage (time frame: 24 hours). 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 NCT02277808, which also lists 3 linked publications.
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 29 Oct 2014.