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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-23

Study Completion Date

2025-02-12

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type SHAM_COMPARATOR

delivery of 99mTc-DTPA aerosol

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

intrapulmonary percussive ventilation

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No