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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Idiopathic Pulmonary Fibrosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05366387

22.00149.000065 (Other Identifier)

DR210241

2021-A02003-38 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Aerosol delivery without intrapulmonary percussive ventilation (Control condition)

Sham Comparator group

Description:

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.

Treatment:

Radiation: delivery of 99mTc-DTPA aerosol

Aerosol delivery with intrapulmonary percussive ventilation (IPV condition)

Active Comparator group

Description:

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.

Treatment:

Device: intrapulmonary percussive ventilation

Radiation: delivery of 99mTc-DTPA aerosol