Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- University Hospital, Tours
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Phase 1: Discomfort during IPV
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Phase 1: Discomfort during IPV
Time Frame: 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
Time Frame: 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 Outcomes
- Phase 1: Incidence of Treatment-Emergent Adverse Events(immediately after IPV (Visit 1) until 15 days after IPV (V2))
- Phase 1: IPV-induced variations in cough(Before IPV (Visit 1) and 15 days after IPV (Visit 2))
- Phase 1: IPV-induced variations in Forced Vital Capacity(Before IPV (Visit 1) and 15 days after IPV (Visit 2))
- Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)(Before IPV (Visit 1) and 15 days after IPV (Visit 2))
- 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))
- Phase 1: Sensations associated with IPV in patients with IPF(immediately after IPV (Visit 1))
- Phase 1: IPV-induced variations in dyspnea(Before IPV (Visit 1) and 15 days after IPV (Visit 2))
- Incidence of Treatment-Emergent Adverse Events one month after treatment(1-month after the last aerosol delivery (V6))
- Phase 1: IPV-induced variations in 5 Hz respiratory reactance(Before IPV (Visit 1) and 15 days after IPV (Visit 2))
- Phase 2: Ratio of deposition of the 99mTc-labelled DTPA aerosol in fibrotic lung versus normal lung(After aerosol delivery in the Control condition)