Healthy SubjectsNCT01913184
Lung Bioavailability With Continuous or Discontinuous Nebulization
A study testing AKITA in people with Healthy Subjects, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To compare the continuous and sicontinuous delivery of drug with AKITA. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AKITA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to Jun 2012
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- no lung disease
- no allergy
Who cannot join
- smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY
To compare the continuous and sicontinuous delivery of drug with AKITA.
- Conditions
- Healthy Subjects
- Being tested
- AKITA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKITADevice
| Study group | Role | What they receive |
|---|---|---|
| Continuous nebulization | Active comparator | Continuous nebulization with AKITA Receives: Device: AKITA |
| Discontinuous nebulization | Experimental | Discontinuous nebulization with AKITA Receives: Device: AKITA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung bioavailability by urinary monitoring
Measured: 24h after the nebulization
Secondary outcomes (1)
Duration of the nebulization
Measured: After the nebulization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2012
- Study completionJun 2012
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 Healthy SubjectsStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913184
- Sponsor's protocol ID
- AKITA continuous
- Status last verified
- Jul 2013
- First submitted
- 29 Jul 2013
- Last updated
- 31 Jul 2013
- Results posted
- No
Publications
Reychler G, Aubriot AS, Masquelier J, Muccioli GG, Liistro G. Effect of drug-targeting nebulization on lung delivery. Arch Bronconeumol. 2014 Nov;50(11):500-1. doi: 10.1016/j.arbres.2013.10.014. Epub 2013 Dec 29. No abstract available. English, Spanish.
PubMed 24380752
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY
- ClinicalTrials.gov ID
- NCT01913184
- Acronym / sponsor ID
- AKITA continuous
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Jul 2013 (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.
To compare the continuous and sicontinuous delivery of drug with AKITA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous nebulization | Active comparator | Device: AKITAContinuous nebulization with AKITA |
| Discontinuous nebulization | Experimental | Device: AKITADiscontinuous nebulization with AKITA |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- no lung disease
- no allergy
Key exclusion criteria (1 listed)
- smoker
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 |
|---|---|---|
| AKITA | Device | Continuous nebulization, Discontinuous nebulization |
Primary outcome
Lung bioavailability by urinary monitoring
Time frame: 24h after the nebulization
1 secondary outcome
Duration of the nebulization
Time frame: After the nebulization
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 2013.
- Derived from this study: PubMed 24380752Reychler G, Aubriot AS, Masquelier J, Muccioli GG, Liistro G. Effect of drug-targeting nebulization on lung delivery. Arch Bronconeumol. 2014 Nov;50(11):500-1. doi: 10.1016/j.arbres.2013.10.014. Epub 2013 Dec 29. No abstract available. English, Spanish.
Related trials for Healthy Subjects
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1/2
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Sickle Cell Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKITA in people with Healthy Subjects, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2013. 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?
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?
Lung bioavailability by urinary monitoring (time frame: 24h after the nebulization). 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 NCT01913184, 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 2013.