Pulmonary Deposition of Ultrasound Rock Salt Aerosol Inhalation Therapy

NCT06891274 | Not Yet Recruiting

• 1 other identifier: 2024-HX-175
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

In the in vitro modeling phase, the investigators plan to use a realistic human upper respiratory tract model and an asymmetric ideal bronchial tree model. By combining 3D printing experiments with CFD simulations, the investigators will investigate the respiratory tract deposition rate and distribution of micro - moist particles in ultrasound rock salt aerosol inhalation therapy. This will be compared with a small - volume nebulizer to verify the effectiveness of ultrasound rock salt aerosol inhalation therapy and lay the foundation for further research on the application of this inhalation technique to other drug formulations. In the clinical phase, the investigators plan to have subjects inhale radioactive aerosols and use PET/CT imaging technology to assess the deposition rate of aerosol particles in the lungs. By quantitatively analyzing the images, the investigators will study their distribution characteristics in real human bodies to verify the accuracy of the in vitro models and the potential for clinical application.

Conditions

COPD; Asthma Bronchiale; Chronic Bronchitis

Keywords

Ultrasound Rock Salt Aerosol Inhalation Therapy; Pulmonary deposition rate; small volume nebulizer

Outcome Measures

Primary Outcomes (2)

• In Vitro Model Pulmonary Deposition Rate

  Aerosol lung deposition rate calculated by in vitro model

  Immediately after nebulization

• Pulmonary Drug Deposition Rate

  Defined as the percentage of drug deposition in the lungs, relative to the whole inhalation volume

  Immediately after nebulization

Study Arms (2)

USN before SVN

EXPERIMENTAL

The group that received ultrasonic rock salt aerosol inhalation therapy followed by small-volume nebulized inhalation therapy.

Device: USN before SVN

SVN before USN

EXPERIMENTAL

The group that received small-volume nebulized inhalation therapy followed by ultrasonic rock salt aerosol inhalation therapy.

Device: SVN before USN

Interventions

USN before SVN DEVICE

The group that received ultrasonic rock salt aerosol inhalation therapy followed by small-volume nebulized inhalation therapy.

USN before SVN

SVN before USN DEVICE

The group that received small-volume nebulized inhalation therapy followed by ultrasonic rock salt aerosol inhalation therapy.

Also known as: Group B

SVN before USN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers; Patients with chronic airway disease requiring nebulization therapy.

You may not qualify if:

• Those aged \< 18 years; Refusing to participate in the study; Patients requiring invasive ventilator assisted breathing; Patients with artificial airways. Patients with chronic liver and kidney function injury. Allergic to radioactive elements.

Sponsors & Collaborators

• Jingen Xia: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

Location

Related Publications (4)

• Wang ST, Bao C, Liu Q, Zhang T, Yang Y, Tian X, Zhu Z, Xu KF. Ga-68 EDTA aerosols in evaluation of inhaled-particle deposition and clearance of obstructive pulmonary diseases: A pilot prospective study compared with Galligas. Eur J Clin Invest. 2021 Dec;51(12):e13620. doi: 10.1111/eci.13620. Epub 2021 Jun 2.

  PMID: 34076256 BACKGROUND

• Bar-Yoseph R, Kugelman N, Livnat G, Gur M, Hakim F, Nir V, Bentur L. Halotherapy as asthma treatment in children: A randomized, controlled, prospective pilot study. Pediatr Pulmonol. 2017 May;52(5):580-587. doi: 10.1002/ppul.23621. Epub 2016 Oct 10.

  PMID: 27723955 BACKGROUND

• Zhang C, Zhu W, Meng Q, Lian N, Wu J, Liu B, Wang H, Wang X, Gu S, Wen J, Shen X, Li Y, Qi X. Halotherapy relieves chronic obstructive pulmonary disease by alleviating NLRP3 inflammasome-mediated pyroptosis. Ann Transl Med. 2022 Dec;10(23):1279. doi: 10.21037/atm-22-5632.

  PMID: 36618788 BACKGROUND

• Tanni S, Wehrmeister F, Prudente R, Damatto F, Breda Neto C, Oliveira L, Pagan L, Gatto M, Vieira L, Coelho L, Rezende D, Machado L, Mota G, Gaiato M, Santaella F, Campos E, Franco E, Callegari M, Okoshi MP, Weinreich U. Efficacy of BREATHOX(R) Device Inhalation on Acute Symptoms Associated with COVID-19 (BREATH Study): A Randomized Pilot Clinical Trial. J Clin Med. 2023 Sep 20;12(18):6075. doi: 10.3390/jcm12186075.

  PMID: 37763015 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Jingen Xia, M.D

  China-Japan Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

Jingen Xia, M.D

CONTACT

+8613466396561; xiajingen_00632@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: March 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)