Bronchiectasis AdultFisioFEVNCT06820918
Physiotherapy With Positive Expiratory Pressure (PEP) Bottle in Patients With Bronchiectasis
A study testing Bottle PEP in people with Bronchiectasis Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Bottle PEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject over 18 years of age
- Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.
- Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery >1
- Absence of normal bronchial tapering
- Visibility of the airways within 1 cm from the pleura
- Subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml)
- Patients capable of performing physiotherapy using the PEP bottle
- Patients capable of performing global spirometry
Who cannot join
- Subject already undergoing regular respiratory physiotherapy
- Subject without significant bronchial hypersecretion
- Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia
- Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.
- Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation <0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).
- Contraindications to PEP-Bottle Physiotherapy (Pneumothorax; Hemoptysis; Myocardial infarction in the 4 weeks prior to informed consent signature)
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- Exacerbation of disease in the previous 4 weeks
- Use of inhalation therapy in the 4 weeks prior to informed consent signature
- Active smoker
- Subject undergoing non-invasive ventilation or with a tracheostomy
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli
Rome, RM, 00168
About this study
Official title: Impact of Physiotherapy With Positive Expiratory Pressure (PEP) Bottle on Respiratory Function in Patients With Bronchiectasis (FisioFEV)
The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
- Conditions
- Bronchiectasis Adult
- Being tested
- Bottle PEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle PEPDevice
Home respiratory physiotherapy using the PEP bottle for a minimum of 10 minutes to a maximum of 30 minutes, twice a day (morning and evening), every day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with bronchiectasis | Experimental | Not described Receives: Device: Bottle PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second)
To evaluate the effect of respiratory physiotherapy using the PEP bottle on respiratory function in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start4 Feb 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Jun 2026 (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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RICHELDI LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820918
- Sponsor's protocol ID
- 6836
- Acronym
- FisioFEV
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physiotherapy With Positive Expiratory Pressure (PEP) Bottle on Respiratory Function in Patients With Bronchiectasis (FisioFEV)
- ClinicalTrials.gov ID
- NCT06820918
- Acronym / sponsor ID
- FisioFEV / 6836
- Conditions
- Bronchiectasis Adult
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 11 Feb 2025 (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 this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bronchiectasis | Experimental | Device: Bottle PEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject over 18 years of age
- Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.
- Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery >1
- Absence of normal bronchial tapering
- Visibility of the airways within 1 cm from the pleura
Key exclusion criteria (11 listed)
- Subject already undergoing regular respiratory physiotherapy
- Subject without significant bronchial hypersecretion
- Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia
- Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.
- Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation <0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).
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 |
|---|---|---|
| Bottle PEPHome respiratory physiotherapy using the PEP bottle for a minimum of 10 minutes to a maximum of 30 minutes, twice a day (morning and evening), every day for 30 days | Device | Patients with bronchiectasis |
Primary outcome
To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second)
Time frame: 60 days
To evaluate the effect of respiratory physiotherapy using the PEP bottle on respiratory function in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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 Bottle PEP in people with Bronchiectasis Adult, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second) (time frame: 60 days). 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 11 Feb 2025.