COPDNCT05420740
Impact of Aerobika OPEP in Improving Small Airway Parameters in COPD
A study testing Aerobika OPEP in people with COPD, run by National University of Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Aerobika OPEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Impact of Aerobika® Oscillating Positive Expiratory Pressure (OPEP) in Improving Small Airway Disease and COPD Assessment Test (CAT) Score in Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the detailed 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®.
- Conditions
- COPD
- Being tested
- Aerobika OPEP
- Keywords
- COPD, Small airway disease, Impulse Oscillometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobika OPEPDevice
Subjects given Aerobika OEP to assess changes in small airway disease parameter , CAT Score , 6 minute walking test and exacerbation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Aerobika OPEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months and 6 months
Secondary outcomes (4)
To evaluate change of CAT score
Comparing change of CAT Score using questionairre pre and post introduction of Aerobika OPEP. Cat Score range 0-40 (0-not affected by symptoms, 40 marked affected by symptoms)
Measured: 3 and 6 months.
To evaluate changes of lung function (using spirometry)
Comparing changes of lung function (FEV1 %) pre and p ost introduction of Aerobika OPEP
Measured: 3 and 6 months.
To evaluate changes of exercise capacity in metres (using 6-minute walking test)
Comparing changes of exercise capacity in metres (using 6-minute walking test) OPEP
Measured: 3 and 6 months.
To evaluate moderate and severe exacerbation rates after Aerobika® OPEP device usage
Comparing frequency of exacerbation (number of events ) and number of hospital admissions
Measured: 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Apr 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420740
- Sponsor's protocol ID
- FF-2021-175
- Status last verified
- Nov 2023
- First submitted
- 9 May 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobika® Oscillating Positive Expiratory Pressure (OPEP) in Improving Small Airway Disease and COPD Assessment Test (CAT) Score in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05420740
- Acronym / sponsor ID
- FF-2021-175
- Conditions
- COPD
- Keywords
- COPD, Small airway disease, Impulse Oscillometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with Small Airway Disease | Experimental | Device: Aerobika OPEPSubjects will be given Aerobika OPEP and IOS, CAT score, Spirometry, 6MWT and Exacerbation were assessed at Week 0, Week 12 and Week 24 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobika OPEPSubjects given Aerobika OEP to assess changes in small airway disease parameter , CAT Score , 6 minute walking test and exacerbation | Device | COPD patients with Small Airway Disease |
Primary outcome
To demonstrate change of small airway parameter using impulse oscillometry after introduction of Aerobika® OPEP among COPD patients .
Time frame: 3 months and 6 months
Comparing change of small airway parameters using impulse oscillometry pre and post introduction of Aerobika OPEP; Parameters used are R5, R5-R20, X5,AX
4 secondary outcomes
To evaluate change of CAT score
Time frame: 3 and 6 months.
To evaluate changes of lung function (using spirometry)
Time frame: 3 and 6 months.
To evaluate changes of exercise capacity in metres (using 6-minute walking test)
Time frame: 3 and 6 months.
To evaluate moderate and severe exacerbation rates after Aerobika® OPEP device usage
Time frame: 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Cost-effectiveness of the Aerobika\* oscillating positive expiratory pressure device in the management of COPD exacerbations. Int J Chron Obstruct Pulmon DisLink provided by the sponsor.
- Economic Burden of Chronic Obstructive Pulmonary Disease Patients in Malaysia: A Longitudinal StudyLink provided by the sponsor.
- Significances of spirometry and impulse oscillometry for detecting small airway disorders assessed with endobronchial optical coherence tomography in COPDLink provided by the sponsor.
- Small Airway Disease in Asthma and COPD: Clinical ImplicationsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobika OPEP in people with COPD, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate change of small airway parameter using impulse oscillometry after introduction of Aerobika® OPEP among COPD patients . (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.