Cystic FibrosisNCT02535130
Evaluation of Nebulization and Positive Expiratory Pressure Combination
A study testing Positive expiratory pressure and amikacine nebulization in people with Cystic Fibrosis and Healthy Subjects, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Healthy Subjects
- What is being tested?
- Positive expiratory pressure and amikacine nebulization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2015to Jun 2018
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Stable cystic fibrosis patients older than 16 y.o.
- Healthy subjects
Who cannot join
- Kidney failure
- No pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Anne-Sophie Aubriot, PT, +3227647020, as.aubriot@gmail.com
Anne-Sophie Aubriot, PT
About this study
The purpose of this study is to compare the efficiency of nebulization and positive expiratory pressure combination
- Conditions
- Cystic Fibrosis, Healthy Subjects
- Being tested
- Positive expiratory pressure, amikacine nebulization
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive expiratory pressureDevice
amikacine nebulizationDrug
| Study group | Role | What they receive |
|---|---|---|
| Nebulization combined to positive expiratory pressure | Experimental | Experimental arm Receives: Device: Positive expiratory pressure; Drug: amikacine nebulization |
| Nebulization | Active comparator | Control arm Receives: Drug: amikacine nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of amikacin
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Measured: 24 hours after the nebulization
Secondary outcomes (1)
breathing pattern
recoding of frequency and tidal volume during the nebulization
Measured: participants will be recorded for the duration of the nebulization, an expected average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionJun 2018 (estimated)
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535130
- Sponsor's protocol ID
- NebuPEP
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Aubriot AS, Leal T, Dubus JC, Gohy S, Reychler G. Impact of adding positive expiratory pressure to nebulisation on drug delivery: a comparative study. Physiotherapy. 2026 Jun;131:101772. doi: 10.1016/j.physio.2025.101772. Epub 2025 Feb 13.
PubMed 40199650
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nebulization and Positive Expiratory Pressure Combination
- ClinicalTrials.gov ID
- NCT02535130
- Acronym / sponsor ID
- NebuPEP
- Conditions
- Cystic Fibrosis, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jun 2018 (estimated)
- First posted
- 28 Aug 2015 (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 compare the efficiency of nebulization and positive expiratory pressure combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulization combined to positive expiratory pressure | Experimental | Device: Positive expiratory pressure, Drug: amikacine nebulizationExperimental arm |
| Nebulization | Active comparator | Drug: amikacine nebulizationControl arm |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Stable cystic fibrosis patients older than 16 y.o.
- Healthy subjects
Key exclusion criteria (2 listed)
- Kidney failure
- No pregnancy
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 |
|---|---|---|
| Positive expiratory pressure | Device | Nebulization combined to positive expiratory pressure |
| amikacine nebulization | Drug | Nebulization, Nebulization combined to positive expiratory pressure |
Primary outcome
Urinary excretion of amikacin
Time frame: 24 hours after the nebulization
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
1 secondary outcome
breathing pattern
Time frame: participants will be recorded for the duration of the nebulization, an expected average of 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 40199650Aubriot AS, Leal T, Dubus JC, Gohy S, Reychler G. Impact of adding positive expiratory pressure to nebulisation on drug delivery: a comparative study. Physiotherapy. 2026 Jun;131:101772. doi: 10.1016/j.physio.2025.101772. Epub 2025 Feb 13.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive expiratory pressure and amikacine nebulization in people with Cystic Fibrosis and 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 2 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 17 Aug 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of amikacin (time frame: 24 hours 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 NCT02535130, 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 17 Aug 2016.