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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

intrapulmonary percussive ventilation

delivery of 99mTc-DTPA aerosol

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring aerosol, deposition, Intrapulmonary Percussive Ventilation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Pulmonology Department, University Hospital, ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Aerosol delivery without intrapulmonary percussive ventilation (Control condition)

Aerosol delivery with intrapulmonary percussive ventilation (IPV condition)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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"

Phase 1: IPV-induced variations in dyspnea

Dyspnea-12 scale

Phase 1: IPV-induced variations in cough

Leicester Cough Questionnaire

Phase 1: IPV-induced variations in Forced Vital Capacity

Spirometry Forced vital capacity is expressed in liters

Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)

Single breath test DLCO is expressed in mL/min/mmHg

Phase 1: IPV-induced variations in 5 Hz respiratory reactance

Impulse oscillometry 5 Hz reactance is expressed as kPa.s/L

Phase 1: Incidence of Treatment-Emergent Adverse Events

Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization

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

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

Incidence of Treatment-Emergent Adverse Events one month after treatment

Telephone interview to assess for : Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization

Full Information

NCT ID

NCT05366387

First Posted

March 25, 2022

Last Updated

December 7, 2022

Sponsor

University Hospital, Tours

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05366387

Brief Title

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

Acronym

AEROPERC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 23, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Fibrosis

Keywords

aerosol, deposition, Intrapulmonary Percussive Ventilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aerosol delivery without intrapulmonary percussive ventilation (Control condition)

Arm Type

Sham Comparator

Arm Description

Arm Title

Aerosol delivery with intrapulmonary percussive ventilation (IPV condition)

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

intrapulmonary percussive ventilation

Intervention Description

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

Radiation

Intervention Name(s)

delivery of 99mTc-DTPA aerosol

Intervention Description

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 Outcome Measure Information:

Title

Phase 1: Discomfort during IPV

Description

Time Frame

immediately after IPV (visit V1)

Title

Phase 2: Change between Control and IPV condition in amount of 99mTc-labelled DTPA aerosol deposited in fibrotic lung regions, reported to loaded dose

Description

Time Frame

After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month

Secondary Outcome Measure Information:

Title

Phase 1: Sensations associated with IPV in patients with IPF

Description

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)

Title

Phase 1: IPV-induced variations in dyspnea

Description

Dyspnea-12 scale

Time Frame