Clinical trial NCT06425562: The Potential Added Value of Impulse Oscillometry in Asthma Monitoring
Official title: The Potential Added Value of Impulse Oscillometry in Asthma Monitoring
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: impulse oscillometry
asthma monitoring
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2024-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Unstable asthma (defined as need for oral corticosteroids or (respiratory) antibiotic course in the 4 weeks before inclusion or any major medical issue in the 4 weeks before inclusion)

Primary outcomes:
measure: Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in area of reactance (AX) stratified according to change in asthma control test (ACT)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control test (ACT)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
Secondary outcomes:
measure: Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma quality of life questionnaire (AQLQ)
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in frequency dependence of resistance (FDR) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for FDR.
timeFrame: Once at baseline and 3 - 6 months later during follow-up
measure: Change in area of reactance (AX) over the 3-6 months observation period compared to proposed minimal clinically important differences (MCIDs) (calculated for a one year interval) for AX.
timeFrame: Once at baseline and 3 - 6 months later during follow-up
Other outcomes:
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