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

Idiopathic Pulmonary Fibrosis Clinical Trial

— AEROPERC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366387
• Other study ID #: DR210241
• Secondary ID: 2021-A02003-3822
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2022
• Est. completion date: May 2024

Study information

• Verified date: December 2022
• Source: University Hospital, Tours
• Contact: Laurent PLANTIER, MD-PhD
• Phone: 02 47 47 98 44
• Email: laurent.plantier[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Device:
• 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.

Radiation:
• 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

Locations

Country	Name	City	State
France	Pulmonology Department, University Hospital, Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month
Primary	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)
Primary	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	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"	immediately after IPV (Visit 1)
Secondary	Phase 1: IPV-induced variations in dyspnea	Dyspnea-12 scale	Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Secondary	Phase 1: IPV-induced variations in cough	Leicester Cough Questionnaire	Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Secondary	Phase 1: IPV-induced variations in Forced Vital Capacity	Spirometry Forced vital capacity is expressed in liters	Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Secondary	Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)	Single breath test DLCO is expressed in mL/min/mmHg	Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Secondary	Phase 1: IPV-induced variations in 5 Hz respiratory reactance	Impulse oscillometry 5 Hz reactance is expressed as kPa.s/L	Before IPV (Visit 1) and 15 days after IPV (Visit 2)
Secondary	Phase 1: Incidence of Treatment-Emergent Adverse Events	Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization	immediately after IPV (Visit 1) until 15 days after IPV (V2)
Secondary	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	After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 5)
Secondary	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	After aerosol delivery in the Control condition
Secondary	Incidence of Treatment-Emergent Adverse Events one month after treatment	Telephone interview to assess for : Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization	1-month after the last aerosol delivery (V6)