Idiopathic Pulmonary FibrosisAEROPERCNCT05366387
Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
A study testing intrapulmonary percussive ventilation and delivery of 99mTc-DTPA aerosol in people with Idiopathic Pulmonary Fibrosis, run by University Hospital, Tours at 1 site in France.
Trial summary
This protocol aims to evaluate the feasibility and benefit of Intrapulmonary Percussive Ventilation (IPV) to improve deposition of inhaled radiolabelled aerosols in fibrotic lung regions of patients with Idiopathic Pulmonary Fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- intrapulmonary percussive ventilation and delivery of 99mTc-DTPA aerosol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2022to 12 Feb 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
- Affiliation to health insurance
- Signed informed consent
Who cannot join
- Other chronic lung disease
- Airflow obstruction (FEV1/FVC<0.7)
- History of congestive heart failure
- History of IPF exacerbation
- History of lung cancer
- Chronic cough precluding aerosol delivery and radioprotection
Show all 16Show fewer
- Claustrophobia
- 24h/24 oxygen therapy
- Any acute lung disease
- Any potentially transmissible lung infection
- Current or possible pregnancy and breastfeeding
- Contra-indications to IPV : Emphysema, recent barotrauma, pneumothorax, pneumomediastinum
- History of pneumothorax or pneumomediastinum
- Patient unable to hold a mouthpiece tightly
- Patient under legal protection (guardianship, curatorship)
- Contraindication to the administration of Technescan DTPA
Trial locations and contacts
1 site in 1 country.
About this study
This protocol aims to evaluate the feasibility and benefit of Intrapulmonary Percussive Ventilation (IPV) to improve deposition of inhaled radiolabelled aerosols in fibrotic lung regions of patients with Idiopathic Pulmonary Fibrosis (IPF).
Phase 1 of the protocol aims to identify the highest IPV pressure that is tolerated by individual patients. Secondary endpoints explore safety of IPV in IPF patients.
Phase 2 of the protocol is a crossover randomized trial where patients will inhale 99mTc-labelled DiethyleneTriamine PentaAcetate (DTPA) aerosols with or without IPV. Aerosol deposition in HRCT-defined fibrotic regions of interest (ROI) is described by Single Photon Emission Computed Tomography (SPECT).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- intrapulmonary percussive ventilation, delivery of 99mTc-DTPA aerosol
- Keywords
- aerosol, deposition, Intrapulmonary Percussive Ventilation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrapulmonary percussive ventilationDevice
Intrapulmonary percussive ventilation is a non invasive ventilation technique where small boli or air are delivered, at adjustable frequency and pressure, to the upper airways though a mouthpiece. IPV is currently used in the clinic to aid with airway clearance in neuromuscular and airway diseases.
delivery of 99mTc-DTPA aerosolRadiation
A 99mTc-DTPA aerosol (500 MBq+/-20%, 3 ml volume) is generated with a jet nebuliser (MMAD 4 µm). The aerosol is inhaled by the study subject and lung deposition is imaged by SPECT
| Study group | Role | What they receive |
|---|---|---|
| Aerosol delivery without intrapulmonary percussive ventilation (Control condition) | Sham comparator | A radiolabelled 99mTc-DTPA aerosol is generated with a jet nebuliser and is inhaled by the subject through a device (connecting tubes, filters) connecting the nebuliser with 1) a mouthpiece and 2) an intrapulmonary percussive ventilation device which is turned off.
Aerosol deposition in fibrotic lung regions is characterized by SPECT imaging. Receives: Radiation: delivery of 99mTc-DTPA aerosol |
| Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) | Active comparator | A radiolabelled 99mTc-DTPA aerosol is generated with a jet nebuliser and is inhaled by the subject through a device (connecting tubes, filters) connecting the nebuliser with 1) a mouthpiece and 2) an intrapulmonary percussive ventilation device which is turned on (frequency=1 Hz, pressure to be determined in phase 1 for each patient, in the 5-40 cm H2O range).
Aerosol deposition in fibrotic lung regions is characterized by SPECT imaging. Receives: Device: intrapulmonary percussive ventilation; Radiation: delivery of 99mTc-DTPA aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Discomfort during IPV
IPV is delivered at increasing pressure (from 5 cm H2O to 40 cm H2O maximum pressure) and discomfort is assessed by a 5-level Likert scale ranging from "no discomfort" to "untolerable discomfort". IPV is stopped when discomfort is rated as "difficult to tolerate" whatever the pressure.
Measured: immediately after IPV (visit V1)
Phase 2: Change between Control and IPV condition in amount of 99mTc-labelled DTPA aerosol deposited in fibrotic lung regions, reported to loaded dose
Following aerosol delivery, chest imaging is done with a SPECT device. SPECT images are fused to high resolution computed tomography (HRCT) images. Fibrotic lung regions regions of interest (ROI) are defined by analysis of HRCT images.
SPECT signal in fibrotic ROI is reported to the radioactive dose that was loaded in the nebulizer
Endpoint is radioactive signal in fibrotic ROI / loaded dose
Measured: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month
Secondary outcomes (10)
Phase 1: Sensations associated with IPV in patients with IPF
5-levels Likert scales ranging from "not at all" to "Very much" are used to answer the following questions : "I have trouble breathing" "This thumps to much" "This is scary"
Measured: immediately after IPV (Visit 1)
Phase 1: IPV-induced variations in dyspnea
Dyspnea-12 scale
Measured: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in cough
Leicester Cough Questionnaire
Measured: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in Forced Vital Capacity
Spirometry Forced vital capacity is expressed in liters
Measured: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)
Single breath test DLCO is expressed in mL/min/mmHg
Measured: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in 5 Hz respiratory reactance
Impulse oscillometry 5 Hz reactance is expressed as kPa.s/L
Measured: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: Incidence of Treatment-Emergent Adverse Events
Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization
Measured: immediately after IPV (Visit 1) until 15 days after IPV (V2)
Phase 2 : Change between Control and IPV condition in total lung deposition of the 99mTc-labelled DTPA aerosol
Ratio of SPECT in total lung / loaded dose
Measured: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 5)
Phase 2: Ratio of deposition of the 99mTc-labelled DTPA aerosol in fibrotic lung versus normal lung
ROI for normally-appearing lung are defined by HRCT. Endpoint is SPECT signal in fibrotic lung ROI / SPECT signal in normally-appearing lung ROI
Measured: After aerosol delivery in the Control condition
Incidence of Treatment-Emergent Adverse Events one month after treatment
Telephone interview to assess for :
Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization
Measured: 1-month after the last aerosol delivery (V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start23 Nov 2022
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Model description
- Phase 1 : Delivery of intrapulmonary percussive ventilation (IPV) to assess for discomfort and adverse effects Phase 2 : Delivery of radiolabelled aerosols with or without IPV, in a crossover design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent PLANTIER, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366387
- Sponsor's protocol ID
- DR210241
- Other IDs
- 2021-A02003-38, 22.00149.000065
- Acronym
- AEROPERC
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2022
- Last updated
- 1 Dec 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05366387
- Acronym / sponsor ID
- AEROPERC / DR210241
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- aerosol, deposition, Intrapulmonary Percussive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 9 May 2022 (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.
This protocol aims to evaluate the feasibility and benefit of Intrapulmonary Percussive Ventilation (IPV) to improve deposition of inhaled radiolabelled aerosols in fibrotic lung regions of patients with Idiopathic Pulmonary Fibrosis (IPF).
Phase 1 of the protocol aims to identify the highest IPV pressure that is tolerated by individual patients. Secondary endpoints explore safety of IPV in IPF patients.
Phase 2 of the protocol is a crossover randomized trial where patients will inhale 99mTc-labelled DiethyleneTriamine PentaAcetate (DTPA) aerosols with or without IPV. Aerosol deposition in HRCT-defined fibrotic regions of interest (ROI) is described by Single Photon Emission Computed Tomography (SPECT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1 : Delivery of intrapulmonary percussive ventilation (IPV) to assess for discomfort and adverse effects Phase 2 : Delivery of radiolabelled aerosols with or without IPV, in a crossover design
| Arm | Type | Receives |
|---|---|---|
| Aerosol delivery without intrapulmonary percussive ventilation (Control condition) | Sham comparator | Radiation: delivery of 99mTc-DTPA aerosolA radiolabelled 99mTc-DTPA aerosol is generated with a jet nebuliser and is inhaled by the subject through a device (connecting tubes, filters) connecting the nebuliser with 1) a mouthpiece and 2) an intrapulmonary percussive ventilation device which is turned off. Aerosol deposition in fibrotic lung regions is characterized by SPECT imaging. |
| Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) | Active comparator | Device: intrapulmonary percussive ventilation, Radiation: delivery of 99mTc-DTPA aerosolA radiolabelled 99mTc-DTPA aerosol is generated with a jet nebuliser and is inhaled by the subject through a device (connecting tubes, filters) connecting the nebuliser with 1) a mouthpiece and 2) an intrapulmonary percussive ventilation device which is turned on (frequency=1 Hz, pressure to be determined in phase 1 for each patient, in the 5-40 cm H2O range). Aerosol deposition in fibrotic lung regions is characterized by SPECT imaging. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
- Affiliation to health insurance
- Signed informed consent
Key exclusion criteria (16 listed)
- Other chronic lung disease
- Airflow obstruction (FEV1/FVC<0.7)
- History of congestive heart failure
- History of IPF exacerbation
- History of lung cancer
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 |
|---|---|---|
| intrapulmonary percussive ventilationIntrapulmonary percussive ventilation is a non invasive ventilation technique where small boli or air are delivered, at adjustable frequency and pressure, to the upper airways though a mouthpiece. IPV is currently used in the clinic to aid with airway clearance in neuromuscular and airway diseases. | Device | Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) |
| delivery of 99mTc-DTPA aerosolA 99mTc-DTPA aerosol (500 MBq+/-20%, 3 ml volume) is generated with a jet nebuliser (MMAD 4 µm). The aerosol is inhaled by the study subject and lung deposition is imaged by SPECT | Radiation | Aerosol delivery with intrapulmonary percussive ventilation (IPV condition), Aerosol delivery without intrapulmonary percussive ventilation (Control condition) |
Primary outcome
Phase 1: Discomfort during IPV
Time frame: immediately after IPV (visit V1)
IPV is delivered at increasing pressure (from 5 cm H2O to 40 cm H2O maximum pressure) and discomfort is assessed by a 5-level Likert scale ranging from "no discomfort" to "untolerable discomfort". IPV is stopped when discomfort is rated as "difficult to tolerate" whatever the pressure.
Phase 2: Change between Control and IPV condition in amount of 99mTc-labelled DTPA aerosol deposited in fibrotic lung regions, reported to loaded dose
Time frame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month
Following aerosol delivery, chest imaging is done with a SPECT device. SPECT images are fused to high resolution computed tomography (HRCT) images. Fibrotic lung regions regions of interest (ROI) are defined by analysis of HRCT images. SPECT signal in fibrotic ROI is reported to the radioactive dose that was loaded in the nebulizer Endpoint is radioactive signal in fibrotic ROI / loaded dose
10 secondary outcomes
Phase 1: Sensations associated with IPV in patients with IPF
Time frame: immediately after IPV (Visit 1)
Phase 1: IPV-induced variations in dyspnea
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in cough
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in Forced Vital Capacity
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in 5 Hz respiratory reactance
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: Incidence of Treatment-Emergent Adverse Events
Time frame: immediately after IPV (Visit 1) until 15 days after IPV (V2)
Phase 2 : Change between Control and IPV condition in total lung deposition of the 99mTc-labelled DTPA aerosol
Time frame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 5)
Phase 2: Ratio of deposition of the 99mTc-labelled DTPA aerosol in fibrotic lung versus normal lung
Time frame: After aerosol delivery in the Control condition
Incidence of Treatment-Emergent Adverse Events one month after treatment
Time frame: 1-month after the last aerosol delivery (V6)
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 1 Dec 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.
Laurent PLANTIER, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrapulmonary percussive ventilation and delivery of 99mTc-DTPA aerosol in people with Idiopathic Pulmonary Fibrosis, run by University Hospital, Tours at 1 site in France.
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 16 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 1 Dec 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 France. 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. Some participants in this study may receive a placebo. 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?
Phase 1: Discomfort during IPV (time frame: immediately after IPV (visit V1)). 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 1 Dec 2025.