Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Radiation: delivery of 99mTc-DTPA aerosolDevice: intrapulmonary percussive ventilation
- Registration Number
- NCT05366387
- Lead Sponsor
- University Hospital, Tours
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
- Affiliation to health insurance
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aerosol delivery without intrapulmonary percussive ventilation (Control condition) delivery of 99mTc-DTPA aerosol 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. Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) intrapulmonary percussive ventilation 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. Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) delivery of 99mTc-DTPA aerosol 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.
- Primary Outcome Measures
Name Time Method Phase 1: Discomfort during IPV immediately after IPV (visit V1) 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 After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month 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
Name Time Method Phase 1: Incidence of Treatment-Emergent Adverse Events immediately after IPV (Visit 1) until 15 days after IPV (V2) Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalization
Phase 1: IPV-induced variations in cough Before IPV (Visit 1) and 15 days after IPV (Visit 2) Leicester Cough Questionnaire
Phase 1: IPV-induced variations in Forced Vital Capacity Before IPV (Visit 1) and 15 days after IPV (Visit 2) Spirometry Forced vital capacity is expressed in liters
Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO) Before IPV (Visit 1) and 15 days after IPV (Visit 2) Single breath test DLCO is expressed in mL/min/mmHg
Phase 2 : Change between Control and IPV condition in total lung deposition of the 99mTc-labelled DTPA aerosol After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 5) Ratio of SPECT in total lung / loaded dose
Phase 1: Sensations associated with IPV in patients with IPF immediately after IPV (Visit 1) 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 Before IPV (Visit 1) and 15 days after IPV (Visit 2) Dyspnea-12 scale
Incidence of Treatment-Emergent Adverse Events one month after treatment 1-month after the last aerosol delivery (V6) Telephone interview to assess for :
Symptomatic pneumothorax Acute exacerbation of IPF requiring hospitalizationPhase 1: IPV-induced variations in 5 Hz respiratory reactance Before IPV (Visit 1) and 15 days after IPV (Visit 2) Impulse oscillometry 5 Hz reactance is expressed as kPa.s/L
Phase 2: Ratio of deposition of the 99mTc-labelled DTPA aerosol in fibrotic lung versus normal lung After aerosol delivery in the Control condition ROI for normally-appearing lung are defined by HRCT. Endpoint is SPECT signal in fibrotic lung ROI / SPECT signal in normally-appearing lung ROI
Trial Locations
- Locations (1)
Pulmonology Department, University Hospital, Tours
🇫🇷Tours, France