Aerosol Drug TherapyNCT01428323
Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets
A study testing Vented and Unvented Jet Nebulizer in people with Aerosol Drug Therapy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear. Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aerosol Drug Therapy
- What is being tested?
- Vented and Unvented Jet Nebulizer
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers between 18 and 60 years old
Who cannot join
- Smokers
- Pathological spirometry
- History of treatment with aminoglygosides 1 month prior the study
- Known allergy to aminoglycosydes
- Any lung pathology or history of lung surgery
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200
Laurent Pitance, PT, +3227645702, laurent.pitance@uclouvain.be
About this study
Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear.
Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.
- Conditions
- Aerosol Drug Therapy
- Being tested
- Vented and Unvented Jet Nebulizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vented and Unvented Jet NebulizerDevice
Also called Nebulizer Type: Sidestream
Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.
What is being measured
The primary outcome is the main question the study is designed to answer.
Amikacin Urinatory excretion
Measured: Each miction during 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerosol Drug TherapyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428323
- Sponsor's protocol ID
- 3.4529.10
- Status last verified
- Sep 2011
- First submitted
- 1 Sep 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets
- ClinicalTrials.gov ID
- NCT01428323
- Acronym / sponsor ID
- 3.4529.10
- Conditions
- Aerosol Drug Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fonds National de la Recherche Scientifique
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 2 Sep 2011 (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.
Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear.
Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Volunteers between 18 and 60 years old
Key exclusion criteria (5 listed)
- Smokers
- Pathological spirometry
- History of treatment with aminoglygosides 1 month prior the study
- Known allergy to aminoglycosydes
- Any lung pathology or history of lung surgery
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 |
|---|---|---|
| Vented and Unvented Jet NebulizerAlso: Nebulizer Type: SidestreamNebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point. | Device | – |
Primary outcome
Amikacin Urinatory excretion
Time frame: Each miction during 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
Related trials for Aerosol Drug Therapy
RecruitingPhase 1
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
Metastatic Ovarian Carcinoma, Peritoneal Carcinomatosis
RecruitingPhase 1
Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors
Peritoneal Carcinomatosis
RecruitingPhase 3
A Randomized Controlled Trial Evaluating the Feasibility and Preliminary Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Advanced Epithelial Ovarian Cancer
Ovarian Cancer
RecruitingPhase 2
The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies
Peritoneal Metastases
Enrolling by invitationPhase 2
PIPAC in Gastric Peritoneal Metastasis
Gastric Cancer Peritoneal Metastases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vented and Unvented Jet Nebulizer in people with Aerosol Drug Therapy, 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 5 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 2 Sep 2011. 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.
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 Laurent NP Pitance, PT (+3227645711, laurent.pitance@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amikacin Urinatory excretion (time frame: Each miction during 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2011.