Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05420740 |
Other study ID # |
FF-2021-175 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2022 |
Est. completion date |
June 1, 2023 |
Study information
Verified date |
November 2023 |
Source |
National University of Malaysia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Research Background Chronic obstructive pulmonary disease (COPD) is a progressive chronic
lung disease that makes breathing difficult with mucus build-up in the inflamed airway and
lungs hyperinflation due to expiratory flow limitation. Global Initiative for Chronic
Obstructive Lung Disease (GOLD) defines COPD as a common, preventable and treatable disease
with significant morbidity and mortality, and incurs intensive expenditure of healthcare
resources. This disease is currently the fourth leading cause of death in the world but is
projected to be the 3rd leading cause of death by 2020. In 2012, global death from COPD
accounted about 6% which equal to more than 3 million deaths in world population. The
mortality burden of COPD is expected to rise to 8.6% by 2030. In Malaysia, the prevalence of
moderate to severe COPD in Malaysia in 2010 is 4.7% which equals to 448,000 cases.
COPD is attributed by long-term exposure to noxious particles and toxic gases. Tobacco
smoking is the main cause of COPD globally. The Third National Health and Morbidity Survey
(NHMS III) conducted in Malaysia in 2006 showed that the prevalence of male ever smokers was
57.6% and in female is 2.5%. Other than that, inhalation of organic or chemical dust and
fumes, and biomass exposure also among the risk factors of COPD. Exposure to noxious
particles will cause activation of inflammatory immune responses. However, continuous and
repetitive exposure towards these noxious particles will lead to tissue remodelling in small
airways causing smooth muscle hypertrophy and fibrosis causing major site of obstruction in
COPD.
In COPD patients, the small airways represent the key sites of airflow obstruction, and small
airway disease (SAD) is considered a functional hallmark of disease. The presence of SAD
progressively increases with higher GOLD classifications and it is closely related to the
high impact of disease measured by COPD Assessment Test (CAT) questionnaire. Distributions of
SAD among COPD patients classified according to GOLD classification. In each of GOLD A, B, C
and D class, the prevalence of SAD are 49%, 88%, 61%, and 96% respectively. As presence of
SAD is closely related to high impact of disease with CAT score ≥10 , they tend to have more
symptoms.
Description:
IOS is a simple, non-invasive method requiring only passive patient cooperation without
special manoeuvre for evaluation of lung function through the measurement of both airway
resistance and airway reactance. The pressure-flow oscillations are applied at the mouth
superimposed on the subject's tidal breaths to measure respiratory system resistance and
reactance at different oscillation frequencies. It uses sound waves to rapidly detect airway
changes. When analysed, these pressure signals separately quantify the degree of obstruction
in the central and peripheral airways. In IOS, it enables measurement of total respiratory
resistance (R5) and proximal respiratory resistance (R20), with the R5-R20 difference
reflecting small airway resistance. Small airway disease is significance if R5-R20 > 0.71
cmH2O/L/sec.
Treatment of COPD requires combination of pharmacological and non-pharmacological approaches.
In non-pharmacological treatment, chest physiotherapy and pulmonary rehabilitation is the
cornerstone of management of COPD patients. It can result in improvement of symptoms,
increased exercise capacity, and improvement in lung functions. By early detection of SAD in
COPD, it enables the physician to offer patients with a more targeted approach therapy, for
example the use of small particle size inhalers or mechanical intervention for example
oscillating positive expiratory device (OPEP), such as Aerobika®.