Excessive Airway SecretionsPHYSIORHEONCT07617142
Impact of Continuous Isotonic Saline Nebulisation Combined With Heated Humidification on the Rheology of Bronchial Secretions.
A study testing Saline Nebulization and Heated humidification in people with Excessive Airway Secretions, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study aims to evaluate whether adding a continuous mist of saltwater (saline nebulization) to warmed, humidified air can improve the properties of mucus in the lungs compared to humidified air alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Airway Secretions
- What is being tested?
- Saline Nebulization and Heated humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Hospitalized in pulmonology unit
- Excessive airways secretions disease: COPD, Bronchiectassies, Cystic Fibrosis, Primary Ciliary Diskynesia
Who cannot join
- Age < 18 years old
- Under invasive or non invasive ventilation
- >15L/min of oxygen
- Mucoactive treatment
- Artificial Upper Airway
- Respiratory Distress
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, 1200
Christophe Thibon, +3227649578, christophe.thibon@saintluc.uclouvain.be
About this study
This study aims to evaluate whether adding a continuous mist of saltwater (saline nebulization) to warmed, humidified air can improve the properties of mucus in the lungs compared to humidified air alone.
Some patients with chronic lung diseases produce large amounts of thick mucus, which can be difficult to clear and may worsen breathing. Making this mucus easier to move and remove could help improve comfort and breathing.
Read more
In this study, 35 adult patients hospitalized for lung conditions with excessive mucus production will participate. Each patient will receive both treatments on two different days, in a random order:
Heated humidified air alone Heated humidified air combined with continuous saline nebulization This design allows each patient to serve as their own comparison. At the beginning and end of each session, a physiotherapist will help patients clear their airways, and mucus samples will be collected. Each treatment session will last 4 hours.
The collected mucus will be analyzed in a laboratory to measure how thick, sticky, or elastic it is, and how much force is needed to move it. The main goal is to determine whether the combined treatment makes mucus easier to clear.
The study will also assess patient comfort, breathing difficulty, ease of clearing mucus, and sleep quality after treatment.
The results of this study may help improve airway care for patients with chronic lung diseases by identifying more effective ways to manage excessive mucus.
Read the detailed description
Aim- The objective of this study is to determine the effect of continuous isotonic saline nebulization combined with heated humidification on mucus rheology characteristics compared with heated humidification alone.
Design study- This experimental study will follow a cross-over design. As mucus rheology characteristics vary among individuals, this design will enable each subject to be his own control.
Population- 35 patients with excessive airway secretions will be included in this study (sample size calculated with a 95% confidence level and 80% power). Patients will undergo screening for eligibility upon admission to the pulmonology unit. Individuals with chronic pulmonary conditions leading to excessive airway secretions (> 20 mL of expectoration per day) and meeting the inclusion criteria will be invited to participate in the study. The study will take place on two days, after inclusion, randomization will determine the sequence of administration for the two treatments being compared.
Intervention- A continuous isotonic saline nebulization will be delivered combined with a heated humidification.
The continuous nebulization will be performed using the Aerogen continuous nebulization set to assure the continuous supply of isotonic saline solution into the aerogen solo mesh nebulizer.
The heated humidification will be delivered by Airvo 3 (Fisher \& Paykel, Auckland, New Zeeland). Air flow will be set at 25L/min, temperature at 37°C and FiO2 will be set to obtain the SpO2 targeted by the physician.
The nebulizer will be installed on the airvo, thus saline particles will be delivered through the nasal prong.
Control- The heated humidification will be delivered by Airvo 3 (Fisher \& Paykel, Auckland, New Zeeland). Air flow will be set at 25L/min, temperature at 37°C and FiO2 21%.
Experimental setting- The study will take place on two days. Subject will experience the intervention and the control treatment on a randomized order.
At the beginning of each experimental session manuals airway clearance maneuvers will be performed by a trained physiotherapist and mucus expectorated will be sampled. After secretion samples subject will undergo treatment, according to the randomization treatment order, for a 4-hour period. A new airway clearance session will be performed at the end pf the 4-hour period with secretion sampling. No Positive Expiratory Pressure or Oscillatory Positive Expiratory Pressure devices will be used to prevent from viscosity modification
Rheological measurements- Rheological measurement will be conducted using the rheometer MCR102 (Anton-Paar,Graz, Austria). Prior to analysis, the sputum will be incubated at 37°C for 30 min before analysis to allow relaxation of the sample. The rheometer comprises two parallels plates which will gently compress the secretion. The lower plate will perform oscillations with controlled angular displacement while the rheometer will measure the torque exerted on the opposite plate during these oscillations. Data will be captured using RheoCompassTM software (Anton-Paar) and various data will be extracted from this analysis.
During the linear phase of the analysis, the investigator will register the elastic modulus (G'), the viscous modulus (G''), the viscoelastic modulus (G*), the damping coefficient (tan δ ratio of G'' and G'). These data will provide insights into the secretion's propensity toward elasticity (solid-like) or viscosity (liquid-like).
During the non-linear phase of the analysis, the investigator will register the critical strain (γc) which represent the secretion's deformability capacity, the critical stress (τc) indicating the force required to initiate sputum flow, and the elastic force (G*p x τc) reflecting the elastic energy of the secretion that must be overcome to induce flow. These data will provide insights into the force required for patient airway clearance.
Outcomes- The primary outcomes will be the difference of the force required to evacuate the secretions between the two treatments (τc).
The secondary outcomes will include:
- Others rheological properties: elastic modulus, viscous modulus, viscoelastic modulus, damping coefficient, critical strain and elastic force.
- Comfort level evaluated using the Likert scale
- Dyspnea intensity assessed using the Modified Borg scale
- Airway clearance difficulty measured using a Visual Analogic Scale (VAS) before and after interventions. Airway clearance difficulty will also be monitored during the twelve hours after interventions.
- Sleep quality after interventions will be assessed using Likert
- Conditions
- Excessive Airway Secretions
- Being tested
- Saline Nebulization, Heated humidification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline NebulizationDevice
Continuous saline nebulization through HFNC
Heated humidificationDevice
Heated humidification through HFNC
| Study group | Role | What they receive |
|---|---|---|
| Saline + Humidification | Experimental | Not described Receives: Device: Saline Nebulization; Device: Heated humidification |
| Humidification | Active comparator | Not described Receives: Device: Heated humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical strain
Rheological property
Measured: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Secondary outcomes (7)
Elastic and viscous modulus
Measured: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Comfort
Lickert scale 0 - 6, higher score is a better outcome
Measured: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Dyspnea
Borge modified scale 0 - 10, higher score is a worse outcome
Measured: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Sleep Quality
Lickert scale 0 - 6, higher score is a better outcome
Measured: 1 day Follow up
Airway clearance difficulty
Lickert Scale 0 - 6; higher score is a better outcome
Measured: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Pulsed oxygen saturation
Measured: Through study completion, 2 days
Cardiac Frequency
Measured: Through study completion, 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Airway SecretionsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Aerogen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617142
- Sponsor's protocol ID
- 2026/10FEV/076
- Acronym
- PHYSIORHEO
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Isotonic Saline Nebulisation Combined With Heated Humidification on the Rheology of Bronchial Secretions.
- ClinicalTrials.gov ID
- NCT07617142
- Acronym / sponsor ID
- PHYSIORHEO / 2026/10FEV/076
- Conditions
- Excessive Airway Secretions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Aerogen
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate whether adding a continuous mist of saltwater (saline nebulization) to warmed, humidified air can improve the properties of mucus in the lungs compared to humidified air alone.
Some patients with chronic lung diseases produce large amounts of thick mucus, which can be difficult to clear and may worsen breathing. Making this mucus easier to move and remove could help improve comfort and breathing.
In this study, 35 adult patients hospitalized for lung conditions with excessive mucus production will participate. Each patient will receive both treatments on two different days, in a random order:
Heated humidified air alone Heated humidified air combined with continuous saline nebulization This design allows each patient to serve as their own comparison. At the beginning and end of each session, a physiotherapist will help patients clear their airways, and mucus samples will be collected. Each treatment session will last 4 hours.
The collected mucus will be analyzed in a laboratory to measure how thick, sticky, or elastic it is, and how much force is needed to move it. The main goal is to determine whether the combined treatment makes mucus easier to clear.
The study will also assess patient comfort, breathing difficulty, ease of clearing mucus, and sleep quality after treatment.
The results of this study may help improve airway care for patients with chronic lung diseases by identifying more effective ways to manage excessive mucus.
Detailed description
Aim- The objective of this study is to determine the effect of continuous isotonic saline nebulization combined with heated humidification on mucus rheology characteristics compared with heated humidification alone.
Design study- This experimental study will follow a cross-over design. As mucus rheology characteristics vary among individuals, this design will enable each subject to be his own control.
Population- 35 patients with excessive airway secretions will be included in this study (sample size calculated with a 95% confidence level and 80% power). Patients will undergo screening for eligibility upon admission to the pulmonology unit. Individuals with chronic pulmonary conditions leading to excessive airway secretions (> 20 mL of expectoration per day) and meeting the inclusion criteria will be invited to participate in the study. The study will take place on two days, after inclusion, randomization will determine the sequence of administration for the two treatments being compared.
Intervention- A continuous isotonic saline nebulization will be delivered combined with a heated humidification.
The continuous nebulization will be performed using the Aerogen continuous nebulization set to assure the continuous supply of isotonic saline solution into the aerogen solo mesh nebulizer.
The heated humidification will be delivered by Airvo 3 (Fisher \& Paykel, Auckland, New Zeeland). Air flow will be set at 25L/min, temperature at 37°C and FiO2 will be set to obtain the SpO2 targeted by the physician.
The nebulizer will be installed on the airvo, thus saline particles will be delivered through the nasal prong.
Control- The heated humidification will be delivered by Airvo 3 (Fisher \& Paykel, Auckland, New Zeeland). Air flow will be set at 25L/min, temperature at 37°C and FiO2 21%.
Experimental setting- The study will take place on two days. Subject will experience the intervention and the control treatment on a randomized order.
At the beginning of each experimental session manuals airway clearance maneuvers will be performed by a trained physiotherapist and mucus expectorated will be sampled. After secretion samples subject will undergo treatment, according to the randomization treatment order, for a 4-hour period. A new airway clearance session will be performed at the end pf the 4-hour period with secretion sampling. No Positive Expiratory Pressure or Oscillatory Positive Expiratory Pressure devices will be used to prevent from viscosity modification
Rheological measurements- Rheological measurement will be conducted using the rheometer MCR102 (Anton-Paar,Graz, Austria). Prior to analysis, the sputum will be incubated at 37°C for 30 min before analysis to allow relaxation of the sample. The rheometer comprises two parallels plates which will gently compress the secretion. The lower plate will perform oscillations with controlled angular displacement while the rheometer will measure the torque exerted on the opposite plate during these oscillations. Data will be captured using RheoCompassTM software (Anton-Paar) and various data will be extracted from this analysis.
During the linear phase of the analysis, the investigator will register the elastic modulus (G'), the viscous modulus (G''), the viscoelastic modulus (G*), the damping coefficient (tan δ ratio of G'' and G'). These data will provide insights into the secretion's propensity toward elasticity (solid-like) or viscosity (liquid-like).
During the non-linear phase of the analysis, the investigator will register the critical strain (γc) which represent the secretion's deformability capacity, the critical stress (τc) indicating the force required to initiate sputum flow, and the elastic force (G*p x τc) reflecting the elastic energy of the secretion that must be overcome to induce flow. These data will provide insights into the force required for patient airway clearance.
Outcomes- The primary outcomes will be the difference of the force required to evacuate the secretions between the two treatments (τc).
The secondary outcomes will include:
- Others rheological properties: elastic modulus, viscous modulus, viscoelastic modulus, damping coefficient, critical strain and elastic force.
- Comfort level evaluated using the Likert scale
- Dyspnea intensity assessed using the Modified Borg scale
- Airway clearance difficulty measured using a Visual Analogic Scale (VAS) before and after interventions. Airway clearance difficulty will also be monitored during the twelve hours after interventions.
- Sleep quality after interventions will be assessed using Likert
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline + Humidification | Experimental | Device: Saline Nebulization, Device: Heated humidification |
| Humidification | Active comparator | Device: Heated humidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Hospitalized in pulmonology unit
- Excessive airways secretions disease: COPD, Bronchiectassies, Cystic Fibrosis, Primary Ciliary Diskynesia
Key exclusion criteria (6 listed)
- Age < 18 years old
- Under invasive or non invasive ventilation
- >15L/min of oxygen
- Mucoactive treatment
- Artificial Upper Airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline NebulizationContinuous saline nebulization through HFNC | Device | Saline + Humidification |
| Heated humidificationHeated humidification through HFNC | Device | Humidification, Saline + Humidification |
Primary outcome
Critical strain
Time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Rheological property
7 secondary outcomes
Elastic and viscous modulus
Time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Comfort
Time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Dyspnea
Time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Sleep Quality
Time frame: 1 day Follow up
Airway clearance difficulty
Time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.
Pulsed oxygen saturation
Time frame: Through study completion, 2 days
Cardiac Frequency
Time frame: Through study completion, 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline Nebulization and Heated humidification in people with Excessive Airway Secretions, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Thibon (+32 27642316, christophe.thibon@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical strain (time frame: On each experimental session (4hours) the outcome will be measured at the onset on the experiment, which mean prior to the application of the treatment / control and at the end of the experiment which mean 4 hours after the onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.