Clinical trial NCT05366387: Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
Official title: Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: aerosol
deposition
Intrapulmonary Percussive Ventilation
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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
Primary purpose: TREATMENT

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).


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
* 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

Primary outcomes:
measure: Phase 1: Discomfort during IPV
timeFrame: immediately after IPV (visit V1)
measure: Phase 2: Change between Control and IPV condition in amount of 99mTc-labelled DTPA aerosol deposited in fibrotic lung regions, reported to loaded dose
timeFrame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 4/5) i.e. up to 1 month
Secondary outcomes:
measure: Phase 1: Sensations associated with IPV in patients with IPF
timeFrame: immediately after IPV (Visit 1)
measure: Phase 1: IPV-induced variations in dyspnea
timeFrame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
measure: Phase 1: IPV-induced variations in cough
timeFrame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
measure: Phase 1: IPV-induced variations in Forced Vital Capacity
timeFrame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
measure: Phase 1: IPV-induced variations in Carbon monoxide transfer factor (DLCO)
timeFrame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
measure: Phase 1: IPV-induced variations in 5 Hz respiratory reactance
timeFrame: Before IPV (Visit 1) and 15 days after IPV (Visit 2)
measure: Phase 1: Incidence of Treatment-Emergent Adverse Events
timeFrame: immediately after IPV (Visit 1) until 15 days after IPV (V2)
measure: Phase 2 : Change between Control and IPV condition in total lung deposition of the 99mTc-labelled DTPA aerosol
timeFrame: After delivery of radiolabelled aerosol under both Control and IPV condition (Visit 5)
measure: Phase 2: Ratio of deposition of the 99mTc-labelled DTPA aerosol in fibrotic lung versus normal lung
timeFrame: After aerosol delivery in the Control condition
measure: Incidence of Treatment-Emergent Adverse Events one month after treatment
timeFrame: 1-month after the last aerosol delivery (V6)
Other outcomes:
measure: Exploratory endpoint : Impact of specific lung lesions on pulmonary ventilation and deposition of the 99mTc-labelled DTPA aerosol
timeFrame: After aerosol delivery under the Control condition (Visit 4 or 5 according to randomization) i.e. up to 1 month
Locations:
city: Tours
country: France
facility: Pulmonology Department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Laurent PLANTIER, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: