CopdNCT06017739
Expiratory Flow Accelerator (Efa) vs Efa + High Flow in Chronic COPD and Bronchiectasis
A study testing Bronchial Clearance A and Bronchial Clearance B in people with Copd and Bronchiectasis Adult, run by Azienda Socio Sanitaria Territoriale della Valle Olona at 1 site in Italy.
Trial summary
The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Copd, Bronchiectasis Adult
- What is being tested?
- Bronchial Clearance A and Bronchial Clearance B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2023to 18 Jan 2025
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosed by spirometry
- Bronchiectasis diagnosed by CT
- 2 Exacerbation/year
Who cannot join
- Cystic Fibrosis
- OSAS
- Non Invasive Ventilation
- Ineffective Cough
- Exacerbation in progress
- Hemodynamic Instability
- severe heart failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Marianna Messina
Somma Lombardo, Varese, 21019
Marianna Messina, +393356509059, marianna.messina@asst-valleolona.it
About this study
Official title: Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow
The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.
- Conditions
- Copd, Bronchiectasis Adult
- Being tested
- Bronchial Clearance A, Bronchial Clearance B
- Keywords
- EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial Clearance ADevice
EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.
Bronchial Clearance BDevice
High Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Flow Accelerator | Experimental | Patients for 6 weeks use the Expiratory Flow Accelerator Technology Receives: Device: Bronchial Clearance A |
| Expiratory Flow Accelerator + HIGH FLOW Technology | Experimental | Patients for 6 weeks use the EFA technology and High Flow Technology Receives: Device: Bronchial Clearance B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Severity
Visual Analogic Scale (0=not severe cough;10=very severe cough)
Measured: "Day0", "Week6", Week13"
Expectoration Difficulty
Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
Measured: "Day0", "Week6", Week13"
Secondary outcomes (7)
FEV 1 (Forced Expiratory Volume)
Airway obstruction index measured by spirometry
Measured: "Day0", "Week6", Week13"
Exacerbations
number of exacerbation/ year
Measured: "Day0", "Week6", Week13"
Inspiratory Capacity
air trapping index measured by spirometry
Measured: "Day0", "Week6", Week13"
6 minutes walking test
index of cardiorespiratory function in activities of daily living
Measured: "Day0", "Week6", Week13"
Saint George Respiratory Questionnaire
quality of life
Measured: "Day0", "Week6", Week13"
Medical Research Council mMRC
dyspnea perception (0 no dyspnea, 4 very important dyspnea)
Measured: "Day0", "Week6", Week13"
SpO2 (Oxygen Saturation by Pulse Oximetry)
blood oxygen saturation
Measured: "Day0", "Week6", Week13"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start9 Oct 2023
- Primary completion18 Jul 2024 (estimated)
- Study completion18 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- the two arms of the study are: 1. EFA / EFA + High Flow 2. EFA + High Flow / EFA patients are randomly assigned to one of two groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale della Valle Olona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIANNA MESSINA, Azienda Socio Sanitaria Territoriale della Valle Olona
- Investigators
- Marianna Messina, Principal investigator, ASST Valle Olona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017739
- Sponsor's protocol ID
- 759del07/08/23
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow
- ClinicalTrials.gov ID
- NCT06017739
- Acronym / sponsor ID
- 759del07/08/23
- Conditions
- Copd, Bronchiectasis Adult
- Keywords
- EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale della Valle OlonaUniversity, hospital or other
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 18 Jul 2024 (estimated)
- Study completion
- 18 Jan 2025 (estimated)
- First posted
- 30 Aug 2023 (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 aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the two arms of the study are: 1. EFA / EFA + High Flow 2. EFA + High Flow / EFA patients are randomly assigned to one of two groups
| Arm | Type | Receives |
|---|---|---|
| Expiratory Flow Accelerator | Experimental | Device: Bronchial Clearance APatients for 6 weeks use the Expiratory Flow Accelerator Technology |
| Expiratory Flow Accelerator + HIGH FLOW Technology | Experimental | Device: Bronchial Clearance BPatients for 6 weeks use the EFA technology and High Flow Technology |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD diagnosed by spirometry
- Bronchiectasis diagnosed by CT
- 2 Exacerbation/year
Key exclusion criteria (7 listed)
- Cystic Fibrosis
- OSAS
- Non Invasive Ventilation
- Ineffective Cough
- Exacerbation in progress
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 |
|---|---|---|
| Bronchial Clearance AEFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day. | Device | Expiratory Flow Accelerator |
| Bronchial Clearance BHigh Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day. | Device | Expiratory Flow Accelerator + HIGH FLOW Technology |
Primary outcome
Cough Severity
Time frame: "Day0", "Week6", Week13"
Visual Analogic Scale (0=not severe cough;10=very severe cough)
Expectoration Difficulty
Time frame: "Day0", "Week6", Week13"
Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
7 secondary outcomes
FEV 1 (Forced Expiratory Volume)
Time frame: "Day0", "Week6", Week13"
Exacerbations
Time frame: "Day0", "Week6", Week13"
Inspiratory Capacity
Time frame: "Day0", "Week6", Week13"
6 minutes walking test
Time frame: "Day0", "Week6", Week13"
Saint George Respiratory Questionnaire
Time frame: "Day0", "Week6", Week13"
Medical Research Council mMRC
Time frame: "Day0", "Week6", Week13"
SpO2 (Oxygen Saturation by Pulse Oximetry)
Time frame: "Day0", "Week6", Week13"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Marianna Messina principal investigator
ASST Valle Olona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial Clearance A and Bronchial Clearance B in people with Copd and Bronchiectasis Adult, run by Azienda Socio Sanitaria Territoriale della Valle Olona 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 7 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 6 Feb 2024. 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 Marianna Messina (+393356509059, annamessina.mm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Severity (time frame: "Day0", "Week6", Week13"). The study lists 2 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 6 Feb 2024.