The Potential Added Value of Impulse Oscillometry in Asthma Monitoring

Asthma Clinical Trial

— AM-IOS  

Official title:

The Potential Added Value of Impulse Oscillometry in Asthma Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425562
• Other study ID #: 24151_AM-IOS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Shane Hanon, Prof. Dr. MD.
• Phone: 02 477 6841
• Email: Shane.Hanon[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Full lung function
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.
• Multiple breath nitrogen washout
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.
• Impulse oscillometry
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Vrije Universiteit Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6)	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 ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	Change in area of reactance (AX) stratified according to change in asthma control questionnaire (ACQ-6)	Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma control questionnaire (ACQ-6)	Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome. The ACQ-6 is a questionnaire which consists of 6 questions, each evaluated on a 7-point Likert-Scale. The total score score is divided by 6 yielding a mean score ranging from 0.0 to 6.0, where a lower score is clinically better than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	Change in frequency dependence of resistance (FDR) stratified according to change in asthma quality of life questionnaire (AQLQ)	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 AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	Change in area of reactance (AX) stratified according to change in asthma quality of life questionnaire (AQLQ)	Area of reactance (AX) is an impulse oscillometry parameter. AX is expressed in kPa/L. A lower AX indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	Change in forced expiratory volume in 1 second (FEV1) stratified according to change in asthma quality of life questionnaire (AQLQ)	Spirometry parameter: forced expiratory volume in 1 second (FEV1). FEV1 is expressed in L. A higher FEV1 indicates a clinically better outcome.The AQLQ is a questionnaire which consists of 32 questions, each evaluated on a 7-point Likert-Scale. The total score is divided by 32 yielding a mean score ranging from 1.0 to 7.0, where a lower score is clinically worse than a higher score.	Once at baseline and 3 - 6 months later during follow-up
Secondary	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.	MCIDs over 1 year have been published for IOS parameters. For frequency dependence of resistance (FDR) the MCID is defined as a decline of FDR greater or equal to 0.06 kPa/(L.s). Change of FDR = 0.06 kPa/(L.s) or not	Once at baseline and 3 - 6 months later during follow-up
Secondary	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.	MCIDs over 1 year have been published for IOS parameters. For area of reactance (AX) the MCID is defined as a decline of AX greater or equal to 0.65 kPa/L. Change of AX = 0.65 kPa/L or not	Once at baseline and 3 - 6 months later during follow-up