The Potential Added Value of Impulse Oscillometry in Asthma Monitoring

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Change in frequency dependance of resistance (FDR) stratified according to change in asthma control test (ACT) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Once at baseline and 3 - 6 months later during follow-up]

Вторичные конечные точки (8)

• Change in frequency dependence of resistance (FDR) stratified according to change in asthma control questionnaire (ACQ-6) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 quality of life questionnaire (AQLQ) [Срок оценки: Once at baseline and 3 - 6 months later during follow-up]
• 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. [Срок оценки: Once at baseline and 3 - 6 months later during follow-up]
• 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. [Срок оценки: Once at baseline and 3 - 6 months later during follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Universitair Ziekenhuis Brussel — Brussels

Идентификаторы

NCT: NCT06425562 · 24151_AM-IOS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗