University Hospital, Tours
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).
Idiopathic Pulmonary Fibrosis
intrapulmonary percussive ventilation
delivery of 99mTc-DTPA aerosol
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 10 participants |
| Masking : | Single |
| 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. |
| Primary Purpose : | Treatment |
| Official Title : | Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis |
| Actual Study Start Date : | November 23, 2022 |
| Estimated Primary Completion Date : | May 2024 |
| Estimated Study Completion Date : | May 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Sham Comparator: Aerosol delivery without intrapulmonary percussive ventilation (Control condition) 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. |
Radiation: delivery of 99mTc-DTPA aerosol |
|
Active Comparator: Aerosol delivery with intrapulmonary percussive ventilation (IPV condition) 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. |
Device: intrapulmonary percussive ventilation |
| Ages Eligible for Study: | 50 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Pulmonology Department, University Hospital, Tours
Tours, France, 37044