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

NCT05366387 | Completed DMC

• 3 other identifiers: DR2102412021-A02003-3822.00149.000065
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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). 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

Keywords

aerosol; deposition; Intrapulmonary Percussive Ventilation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  immediately after IPV (Visit 1)

• Phase 1: IPV-induced variations in dyspnea

  Before IPV (Visit 1) and 15 days after IPV (Visit 2)

• Phase 1: IPV-induced variations in cough

  Before IPV (Visit 1) and 15 days after IPV (Visit 2)

• Phase 1: IPV-induced variations in Forced Vital Capacity

  Before IPV (Visit 1) and 15 days after IPV (Visit 2)

• Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)

  Before IPV (Visit 1) and 15 days after IPV (Visit 2)

Other Outcomes (1)

• Exploratory endpoint : Impact of specific lung lesions on pulmonary ventilation and deposition of the 99mTc-labelled DTPA aerosol

  After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month

Study Arms (2)

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.

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.

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

Interventions

intrapulmonary percussive ventilation DEVICE

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.

Aerosol delivery with intrapulmonary percussive ventilation (IPV condition)

delivery of 99mTc-DTPA aerosol RADIATION

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

Aerosol delivery with intrapulmonary percussive ventilation (IPV condition); Aerosol delivery without intrapulmonary percussive ventilation (Control condition)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• h/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)

Sponsors & Collaborators

• University Hospital, Tours: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Pulmonology Department, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laurent PLANTIER, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Phase 1 : Open label Phase 2 : The primary endpoint is defined by quantitative analysis of SPECT images. Analysis is done by a project Partner (Inserm UMR1101), blinded to treatment arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: May 9, 2022
• Study Start: November 23, 2022
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)