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The Potential Added Value of Impulse Oscillometry in Asthma Monitoring (AM-IOS)

U

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

Asthma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06425562
24151_AM-IOS

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Adult asthma patients
Experimental group
Description:
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.
Treatment:
Other: Impulse oscillometry
Other: Full lung function
Other: Multiple breath nitrogen washout

Trial contacts and locations

1

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Central trial contact

Shane Hanon, Prof. Dr. MD.

Data sourced from clinicaltrials.gov

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