Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis (AEROPERC)

November 27, 2025 updated by: University Hospital, Tours

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Tours, France, 37044
        • Pulmonology Department, University Hospital, Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
  • Affiliation to health insurance
  • Signed informed consent

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Aerosol delivery without intrapulmonary percussive ventilation (Control condition)

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.
Radiation: delivery of 99mTc-DTPA aerosol
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
Active Comparator: Aerosol delivery with intrapulmonary percussive ventilation (IPV condition)

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.
Radiation: delivery of 99mTc-DTPA aerosol
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
Device: intrapulmonary percussive ventilation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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
After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1: Sensations associated with IPV in patients with IPF
Time Frame: immediately after IPV (Visit 1)
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"
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)
Dyspnea-12 scale
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)
Leicester Cough Questionnaire
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)
Spirometry Forced vital capacity is expressed in liters
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)
Single breath test DLCO is expressed in mL/min/mmHg
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)
Impulse oscillometry 5 Hz reactance is expressed as kPa.s/L
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)
Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization
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)
Ratio of SPECT in total lung / loaded dose
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
ROI for normally-appearing lung are defined by HRCT. Endpoint is SPECT signal in fibrotic lung ROI / SPECT signal in normally-appearing lung ROI
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)

Telephone interview to assess for :

Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization
1-month after the last aerosol delivery (V6)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exploratory endpoint : Impact of specific lung lesions on pulmonary ventilation and deposition of the 99mTc-labelled DTPA aerosol
Time Frame: After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month

Additional ROI are defined on HRCT to define predominant lung lesions as either "ground glass opacities", "reticulations", or "bronchiectasis".

The impact of these lesions on pulmonary ventilation and aerosol deposition is described as :

  • pulmonary ventilation : Fusion of HRCT images with 88mKr-ventilation SPECT images.
  • aerosol deposition : Fusion of HRCT images with 99mTc-DTPA aerosol deposition images.
After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent PLANTIER, MD-PhD, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR210241
  • 2021-A02003-38 (Other Identifier: IdRCB)
  • 22.00149.000065 (Other Identifier: CPP (SI RIPH 2G))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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