Effect of Intrapulmonary Percussion Ventilation on Deposition of Inhaled Aerosols in Idiopathic Pulmonary Fibrosis

Last updated: December 7, 2022
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Cystic Fibrosis

Lung Injury

Treatment

N/A

Clinical Study ID

NCT05366387
DR210241
22.00149.000065
2021-A02003-38
  • Ages > 50
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines
  • Affiliation to health insurance
  • Signed informed consent

Exclusion

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

Study Design

Total Participants: 10
Study Start date:
November 23, 2022
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Pulmonology Department, University Hospital, Tours

    Tours, 37044
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.