- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07722377
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects (PHYSIOCLEAR)
Mucociliary clearance is an essential defense mechanism of the lungs that helps remove inhaled particles, pathogens, and airway secretions. This process depends on the coordinated action of cilia, mucus properties, and airway hydration. In healthy individuals, mucus is continuously transported toward the throat, allowing effective clearance of harmful substances. However, this mechanism can be influenced by the hydration status of the airway surface liquid.
Heated humidification delivered through high-flow nasal cannula (HFNC) has been shown to improve airway hydration, enhance ciliary function, and support mucociliary clearance. In addition, nebulized saline solutions are commonly used to modify mucus properties. Hypertonic saline has demonstrated short-term benefits in improving mucus hydration and clearance, but its use may be associated with side effects such as airway irritation or bronchoconstriction. In contrast, the effects of isotonic saline remain unclear, particularly when delivered in large volumes.
The rationale of this study is that continuous nebulization of isotonic saline, when combined with heated humidification, may provide a sufficient cumulative amount of sodium to improve airway hydration and mucociliary clearance, potentially mimicking the effects of hypertonic saline without its adverse effects.
This study is a randomized controlled cross-over trial conducted in healthy adult volunteers. Each participant will undergo three experimental sessions: a baseline assessment without intervention, a control condition with heated humidification alone, and an intervention condition combining heated humidification with continuous isotonic saline nebulization. The order of the control and intervention sessions will be randomized.
Mucociliary clearance will be assessed using pulmonary scintigraphy. Participants will inhale radiolabeled aerosol particles (99mTc-DTPA), and the clearance of these particles from the lungs will be monitored over time using a gamma camera. Images will be acquired at regular intervals to quantify the rate of particle retention and clearance under each condition.
The primary objective of the study is to determine whether continuous isotonic saline nebulization combined with heated humidification improves mucociliary clearance compared to heated humidification alone.
Secondary outcomes include the evolution of mucociliary clearance over time during and after the intervention, as well as participant comfort assessed using a Likert scale.
The findings of this study may help improve understanding of airway hydration strategies and contribute to optimizing respiratory care techniques aimed at enhancing mucus clearance.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Brussels, Belgien, 1200
- Cliniques Universitaires Saint-Luc
-
Kontakt:
- Christophe Thibon
- Telefonnummer: +32 764 16 23
- E-mail: christophe.thibon@saintluc.uclouvain.be
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- >18 years old
- healthy spiromètry
Exclusion Criteria:
- <18 years old
- Pathologic spiromètry
- Active smokers
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Baseline
|
|
|
Aktiv komparator: Befugtning
|
gas heated humidification through HFNC
|
|
Eksperimentel: Humidification + nebulization
|
gas heated humidification through HFNC
0.9 % Saline continuous nebulization
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mucociliary clearance
Tidsramme: 20 minutes interval from the onset through study completion 2 hours
|
Mucociliary clearance will be assessed using biplane scintigraphy
|
20 minutes interval from the onset through study completion 2 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Confort during the use of the device
Tidsramme: At study completion 2 hours
|
The comfort while using the device will be assessed using a Lickert Scale
|
At study completion 2 hours
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026/09FEV/074
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sunde emner (HS)
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Ikke rekrutterer endnuSunde emner (HS)
-
Shenyang Sunshine Pharmaceutical Co., LTD.Ikke rekrutterer endnu
-
University of ManchesterRekrutteringSunde emner (HS)Det Forenede Kongerige
-
Biotech Pharmaceutical Co., Ltd.Ikke rekrutterer endnuSunde emner (HS)
-
University of VigoIkke rekrutterer endnu
-
Otsuka Beijing Research InstituteOtsuka Pharmaceutical Development & Commercialization, Inc.Afsluttet
-
InSilico Medicine Hong Kong LimitedRekrutteringSunde emner (HS) | Obese Adult Participants at Risk of Cardiovascular DiseaseAustralien
-
Youngstown State UniversityRekruttering
-
The Hong Kong Polytechnic UniversityRekruttering
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Afsluttet
Kliniske forsøg med Heated humidification
-
University Hospital, Clermont-FerrandAfsluttetPostoperativ hypoxæmiFrankrig
-
Altria Client Services LLCICON Clinical ResearchAfsluttetBrug af tobak | TobaksrygningForenede Stater
-
Peking UniversityRekrutteringLuftvejskontrol | Beroligende, hypnotisk eller anxiolytisk abstinensKina