The Potential Added Value of Impulse Oscillometry in Asthma Monitoring

NCT06425562 | Recruiting

• 1 other identifier: 24151_AM-IOS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this longitudinal observational study is to learn if impulse oscillometry (IOS) has an added value in asthma monitoring in adult asthma patients who are prescribed a change in asthma maintenance therapy. The main questions it aims to answer are:

• Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in asthma control test?
• Is there a difference in the change in IOS parameters and FEV1 respectively, stratified according to change in other questionnaire such as the asthma control questionnaire and the asthma quality of life questionnaire.
• Are the proposed minimal clinically important differences (MCIDs) valid for short follow-up periods (3 - 6 months)? Participants will undergo lung function testing (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionnaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire), once during the baseline visit and once during the follow-up visit three to six months later.

Conditions

Asthma

Keywords

impulse oscillometry; asthma monitoring

Outcome Measures

Primary Outcomes (3)

• Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT)

  Frequency dependance of resistance (FDR) is an impulse oscillometry parameter. FDR is expressed in kPa/(L.s). A lower FDR indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.

  Once at baseline and 3 - 6 months later during follow-up

• Change in area of reactance (AX) stratified according to change in asthma control test (ACT)

  Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.

  Once at baseline and 3 - 6 months later during follow-up

• Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control test (ACT)

  Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACT is a questionnaire which consists of 5 questions, each evaluated on a 5-point Likert-Scale. Total score ranges between 5 and 25, where a lower score is clinically worse than a higher score.

  Once at baseline and 3 - 6 months later during follow-up

Secondary Outcomes (8)

• Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6)

  Once at baseline and 3 - 6 months later during follow-up

• Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6)

  Once at baseline and 3 - 6 months later during follow-up

• Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6)

  Once at baseline and 3 - 6 months later during follow-up

• Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ)

  Once at baseline and 3 - 6 months later during follow-up

• Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ)

  Once at baseline and 3 - 6 months later during follow-up

Study Arms (1)

Adult asthma patients

EXPERIMENTAL

Lung function tests (full lung function, multiple breath nitrogen washout, impulse oscillometry) and questionaires (asthma control test, asthma control questionnaire, asthma quality of life questionnaire) will be conducted, once at baseline and once 3 - 6 months later during follow-up.

Other: Full lung function; Other: Multiple breath nitrogen washout; Other: Impulse oscillometry

Interventions

Full lung function OTHER

This includes spirometry, body plethysmography and single breath gas transfer test. These are all non-invasive physiological measurements / lung function tests. Measures flow volumes, lung volumes and gas transfer respectively.

Adult asthma patients

Multiple breath nitrogen washout OTHER

Non-invasive physiological measurement / lung function test. 100% oxygen is inhaled and the nitrogen concentration in the lungs is measured. This test gives information on the ventilation distribution in the lungs.

Adult asthma patients

Impulse oscillometry OTHER

Non-invasive physiological measurement / lung function test. This technique superimposes sound waves on tidal breathing. The patient can breathe normally trough the device, no forced respiratory maneuvers are required. It gives information on the reactance and resistance of the lung.

Adult asthma patients

Eligibility Criteria

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

You may qualify if:

• Adult asthma patients with a scheduled consultation at the outpatient hospital to whom a step-up or step-down of their pharmacological asthma treatment is prescribed

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Shane Hanon, Prof. Dr. MD.

CONTACT

02 477 6841; Shane.Hanon@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 22, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)