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Completed

NCT Number: NCT05366387

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

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).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonology Department, University Hospital, Tours

Tours, 37044, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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"

  2. Phase 1: IPV-induced variations in dyspnea

    Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)

    Dyspnea-12 scale

  3. Phase 1: IPV-induced variations in cough

    Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)

    Leicester Cough Questionnaire

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: AEROPERC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 9, 2022
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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