Impact of Aerobika OPEP in Improving Small Airway Parameters in COPD

NCT05420740 | Completed

• 1 other identifier: FF-2021-175
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD; Small airway disease; Impulse Oscillometry

Outcome Measures

Primary Outcomes (1)

• To demonstrate change of small airway parameter using impulse oscillometry after introduction of Aerobika® OPEP among COPD patients .

  Comparing change of small airway parameters using impulse oscillometry pre and post introduction of Aerobika OPEP; Parameters used are R5, R5-R20, X5,AX

  3 months and 6 months

Secondary Outcomes (4)

• To evaluate change of CAT score

  3 and 6 months.

• To evaluate changes of lung function (using spirometry)

  3 and 6 months.

• To evaluate changes of exercise capacity in metres (using 6-minute walking test)

  3 and 6 months.

• To evaluate moderate and severe exacerbation rates after Aerobika® OPEP device usage

  3 and 6 months.

Study Arms (1)

COPD patients with Small Airway Disease

EXPERIMENTAL

Subjects will be given Aerobika OPEP and IOS, CAT score, Spirometry, 6MWT and Exacerbation were assessed at Week 0, Week 12 and Week 24

Device: Aerobika OPEP

Interventions

Aerobika OPEP DEVICE

Subjects given Aerobika OEP to assess changes in small airway disease parameter , CAT Score , 6 minute walking test and exacerbation

COPD patients with Small Airway Disease

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years or older
• COPD diagnosed according to the GOLD guidelines: GOLD 2 - GOLD 4
• Stable COPD patients with mucus hyperproduction: coughed and brought up sputum "several days a week" (\>2 days a week) or "almost every day" in the month prior to the study
• Patients who can perform IOS
• Patients who can perform spirometry
• Patients who can perform 6MWT

You may not qualify if:

• COPD diagnosed according to the GOLD guidelines: GOLD 1
• Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
• Patients with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
• Patients not recommended for OPEP: neuromuscular weakness, recent facial, oral or skull surgery or trauma, recent oesophageal surgery, active haemoptysis, acute sinusitis, untreated pneumothorax, known or suspected tympanic membrane rupture or other middle ear pathology, overt right-sided heart failure
• Patients with contraindication for 6 minute walking test
• Patient unable or unwilling to give informed consent
• Change of inhaler during study period

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Links

• Cost-effectiveness of the Aerobika\* oscillating positive expiratory pressure device in the management of COPD exacerbations. Int J Chron Obstruct Pulmon Dis
• Economic Burden of Chronic Obstructive Pulmonary Disease Patients in Malaysia: A Longitudinal Study
• Significances of spirometry and impulse oscillometry for detecting small airway disorders assessed with endobronchial optical coherence tomography in COPD
• Small Airway Disease in Asthma and COPD: Clinical Implications

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: June 15, 2022
• Study Start: July 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)