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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02003-38 | Other Identifier | IdRCB | |
| 22.00149.000065 | Other Identifier | CPP (SI RIPH 2G) |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosol delivery without intrapulmonary percussive ventilation (Control condition) | Sham Comparator | 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. |
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| Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrapulmonary percussive ventilation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Phase 1: IPV-induced variations in dyspnea |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent PLANTIER, MD-PhD | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonology Department, University Hospital, Tours | Tours | 37044 | France |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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
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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.
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| delivery of 99mTc-DTPA aerosol | 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 |
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Dyspnea-12 scale |
| Before IPV (Visit 1) and 15 days after IPV (Visit 2) |
| Phase 1: IPV-induced variations in cough | Leicester Cough Questionnaire | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1-month after the last aerosol delivery (V6) |
| After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month |