An interventional study of intrapulmonary percussive ventilation and delivery of 99mTc-DTPA aerosol in Idiopathic Pulmonary Fibrosis, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Treatment
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).
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's enrollment of 9 is below the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
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 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
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.
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
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.
Time frame: 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
Time frame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month
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"
Time frame: immediately after IPV (Visit 1)
Phase 1: IPV-induced variations in dyspnea
Dyspnea-12 scale
Time frame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Phase 1: IPV-induced variations in cough
Leicester Cough Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
Ratio of SPECT in total lung / loaded dose
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
ROI for normally-appearing lung are defined by HRCT. Endpoint is SPECT signal in fibrotic lung ROI / SPECT signal in normally-appearing lung ROI
Time frame: 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
Time frame: 1-month after the last aerosol delivery (V6)
Exploratory endpoint : Impact of specific lung lesions on pulmonary ventilation and deposition of the 99mTc-labelled DTPA aerosol
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.
Time frame: After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Idiopathic Pulmonary Fibrosis→
University Hospital, Tours