Cystic FibrosisNCT02201082
Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
A study testing Airway clearance technique and Amikacin nebulization in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Airway clearance technique and Amikacin nebulization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Jul 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stable cystic fibrosis patients older than 16 y.o.
- Pseudomonas aeruginosa colonization
- Hypersecretion
Who cannot join
- Kidney failure
- No pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.
- Conditions
- Cystic Fibrosis
- Being tested
- Airway clearance technique, Amikacin 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.
Airway clearance techniqueProcedure or surgery
Amikacin nebulizationDrug
| Study group | Role | What they receive |
|---|---|---|
| Nebulization and airway clearance technique | Experimental | nebulization combined to airway clearance Receives: Procedure: Airway clearance technique; Drug: Amikacin nebulization |
| Nebulization | Active comparator | nebulization Receives: Drug: Amikacin 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: 24h after the nebulization
Secondary outcomes (1)
Amikacin concentration into the sputum
Measured: At the end of the nebulization, an expected average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201082
- Sponsor's protocol ID
- Physionebu
- Status last verified
- Aug 2015
- First submitted
- 20 Feb 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
- ClinicalTrials.gov ID
- NCT02201082
- Acronym / sponsor ID
- Physionebu
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jul 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 purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulization and airway clearance technique | Experimental | Procedure: Airway clearance technique, Drug: Amikacin nebulizationnebulization combined to airway clearance |
| Nebulization | Active comparator | Drug: Amikacin nebulizationnebulization |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Stable cystic fibrosis patients older than 16 y.o.
- Pseudomonas aeruginosa colonization
- Hypersecretion
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 |
|---|---|---|
| Airway clearance technique | Procedure or surgery | Nebulization and airway clearance technique |
| Amikacin nebulization | Drug | Nebulization, Nebulization and airway clearance technique |
Primary outcome
Urinary excretion of amikacin
Time frame: 24h after the nebulization
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
1 secondary outcome
Amikacin concentration into the sputum
Time frame: At the end of the nebulization, an expected average of 20 minutes
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 25 Aug 2015.
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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.
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 Airway clearance technique and Amikacin nebulization in people with Cystic Fibrosis, 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 3 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: finished, as of the sponsor's last update on 25 Aug 2015. 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?
Urinary excretion of amikacin (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?
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 25 Aug 2015.