Bronchiectasis AdultBXNCT04142827
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
A study testing High Flow Humidification in people with Bronchiectasis Adult and Lung Infection, run by Dr. Giuseppe Fiorentino at 1 site in Italy.
Trial summary
The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchiectasis Adult, Lung Infection, Quality of Life
- What is being tested?
- High Flow Humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2019to 3 Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Bronchiectasis on HRCT
- Optimization of Therapy for at least 15 days before enrollment
- Autonomous patients with possibilities of practicing rehabilitations cycles
Who cannot join
- OSAS (ODI>10/h)
- HOME NIV
- PH<7,35 - paO2< 60mmHg, paCo2> 55 mmHg
- Lung cancer
- Contraindication to high-flow nasal cannula (hfnc)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rosa Cauteruccio
Naples, 80131
Rosa Cauteruccio, Doctor, +393392193620, rosacauteruccio@gmail.com
About this study
Official title: The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function
- Conditions
- Bronchiectasis Adult, Lung Infection, Quality of Life, Humidifier Lung, COPD Exacerbation, COPD Asthma
- Being tested
- High Flow Humidification
- Keywords
- Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow HumidificationDevice
myAirvo2 gives at home for long therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Therapy with high flow humidification | Experimental | The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations Receives: Device: High Flow Humidification |
| Therapy with usual care | No intervention | The patients will be under usual care for observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvment Daily Life
measurement via questionary SGRQ
Measured: 1 year
measurement of Sputum production
Microbiological Mesurement of sputum
Measured: 1 year
measurement Exercise tolerance
measurement with 6 minutes walking test
Measured: 1 year
Number of missed working or school day
Calculation of days of sick
Measured: 1 year
time from first exacerbations
measurement of time dalay from last exacerbation
Measured: 1 year
number of exacerbations including their durations and severity
counting form their clinic diary of number of exacerbation
Measured: 1 year
Secondary outcomes (3)
Evaluation of Arterial Blood Glass
Arterial Blood Glass draw at time zero and time 1
Measured: 1 year
Unit of Nitric Oxide
Measurement with Nitric oxide device
Measured: 1 year
Evaluation of Reactive C-Protein
comparation of blood draw
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start4 Sep 2019
- Primary completion3 Mar 2020 (estimated)
- Study completion3 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Giuseppe Fiorentino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Giuseppe Fiorentino, Monaldi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142827
- Sponsor's protocol ID
- High Flow in Bronchiectasis
- Acronym
- BX
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
- ClinicalTrials.gov ID
- NCT04142827
- Acronym / sponsor ID
- BX / High Flow in Bronchiectasis
- Conditions
- Bronchiectasis Adult, Lung Infection, Quality of Life, Humidifier Lung, COPD Exacerbation, COPD Asthma
- Keywords
- Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Dr. Giuseppe FiorentinoUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 3 Mar 2020 (estimated)
- Study completion
- 3 Sep 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- 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 study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy with high flow humidification | Experimental | Device: High Flow HumidificationThe patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations |
| Therapy with usual care | No intervention | –The patients will be under usual care for observational |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Bronchiectasis on HRCT
- Optimization of Therapy for at least 15 days before enrollment
- Autonomous patients with possibilities of practicing rehabilitations cycles
Key exclusion criteria (5 listed)
- OSAS (ODI>10/h)
- HOME NIV
- PH<7,35 - paO2< 60mmHg, paCo2> 55 mmHg
- Lung cancer
- Contraindication to high-flow nasal cannula (hfnc)
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 |
|---|---|---|
| High Flow HumidificationmyAirvo2 gives at home for long therapy treatment | Device | Therapy with high flow humidification |
Primary outcome
Improvment Daily Life
Time frame: 1 year
measurement via questionary SGRQ
measurement of Sputum production
Time frame: 1 year
Microbiological Mesurement of sputum
measurement Exercise tolerance
Time frame: 1 year
measurement with 6 minutes walking test
Number of missed working or school day
Time frame: 1 year
Calculation of days of sick
time from first exacerbations
Time frame: 1 year
measurement of time dalay from last exacerbation
number of exacerbations including their durations and severity
Time frame: 1 year
counting form their clinic diary of number of exacerbation
3 secondary outcomes
Evaluation of Arterial Blood Glass
Time frame: 1 year
Unit of Nitric Oxide
Time frame: 1 year
Evaluation of Reactive C-Protein
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: Yes
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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 High Flow Humidification in people with Bronchiectasis Adult and Lung Infection, run by Dr. Giuseppe Fiorentino at 1 site in Italy.
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 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 29 Oct 2019. 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 Italy. 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 Giuseppe Fiorentino, Doctor (+393478482564, giuseppefiorentino1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvment Daily Life (time frame: 1 year). The study lists 6 primary outcomes in all. 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 29 Oct 2019.