Impact of Continuous Isotonic Saline Nebulisation Combined With Heated Humidification on the Rheology of Bronchial Secretions.

NCT07617142 | Not Yet Recruiting

• 1 other identifier: 2026/10FEV/076
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Excessive Airway Secretions

Outcome Measures

Primary Outcomes (1)

• Critical strain

  Rheological property

  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

  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

  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

  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

  1 day Follow up

• Airway clearance difficulty

  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.

Study Arms (2)

Saline + Humidification

EXPERIMENTAL

Device: Saline Nebulization; Device: Heated humidification

Humidification

ACTIVE COMPARATOR

Device: Heated humidification

Interventions

Saline Nebulization DEVICE

Continuous saline nebulization through HFNC

Saline + Humidification

Heated humidification DEVICE

Heated humidification through HFNC

Humidification; Saline + Humidification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Hospitalized in pulmonology unit
• Excessive airways secretions disease: COPD, Bronchiectassies, Cystic Fibrosis, Primary Ciliary Diskynesia

You may not qualify if:

• Age \< 18 years old
• Under invasive or non invasive ventilation
• \>15L/min of oxygen
• Mucoactive treatment
• Artificial Upper Airway
• Respiratory Distress

Sponsors & Collaborators

• Fisher and Paykel Healthcare: collaborator
• Aerogen: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Central Study Contacts

Christophe Thibon

CONTACT

+32 27642316; christophe.thibon@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-05

Locations

BE (1)