Chronic Obstructive Pulmonary Disease With ExacerbationNCT04828837

Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects

A study testing bubble PEP in people with Chronic Obstructive Pulmonary Disease With Exacerbation and Chronic Obstructive Pulmonary Disease Exacerbation, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The morbidity rate of Chronic Obstructive Pulmonary Disease (COPD) is increasing year by year. It is predicted to be the third leading cause of death worldwide in 2030. People with COPD have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Pulmonary Disease
What is being tested?: bubble PEP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteTaiwan
Study dates: 2 Feb 2021to 31 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Hospitalized patients diagnosed with COPD
Over 40 years old
Awareness and ability to read articles
Agree to participate in this research and sign the research consent form

Who cannot join

Use non-invasive positive pressure breathing apparatus
Have received positive pressure breathing therapy before or during hospitalization
People with mental illness
Coughing up blood, pneumothorax
Suffer from legally infectious respiratory diseases
Pregnant women
Reject the subject

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

National Taipei University of Nursing and Heath Sciences
Taipei, Beitou District, 112303

Other trials in Taiwan

About this study

Official title: National Taipei University of Nursing and Heath Sciences

Read the detailed description

This study aimed to explore the effectiveness of cough and sputum assessment and respiratory physiological indicators after training with the Bubble positive expiratory pressure (Bubble PEP) inpatients with COPD. This is a randomization control trial design survey using convenient sampling and will be to select 94 inpatients with COPD in the division of chest ward of two teaching hospital in New Taipei City. The subjects who meet the conditions for admission are explained, and they need to sign a consent form confirming that they understand the risks. More, they are randomly divided into the experimental group (experimental group n=47) and the control group (control group n=47). The experimental group receives the Bubble PEP training; the control group receives the division of chest ward routine care. The study employs a structured questionnaire including a basic demography, COPD domain, COPD assessment test (CAT), cough and sputum assessment test, and check the peak expiratory flow rate (PEFR) using it for data collection. The study needs to be approve by the Institutional Review Board. The two groups agreed to participate in the study, after completing the subject consent form before the intervention, they also received the pre-test as a benchmark for the intervention effect. After completing the 7-day and 30-day intervention, the post-test was performed immediately to understand the intervention immediate effect.

Conditions: Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Pulmonary Disease
Being tested: bubble PEP
Keywords: COPD, Bubble PEP, pulmonary function
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.

bubble PEPDevice
Using the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.

Study groups in NCT04828837
Study group	Role	What they receive
Bubble positive expiratory pressure training	Experimental	The experimental group receives the Bubble PEP training. Receives: Device: bubble PEP
general care	No intervention	The control group receives the division of chest ward routine care.

What is being measured

The primary outcome is the main question the study is designed to answer.

The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
In the CAT, a total of eight items were used to assess the degree of dyspnea of the patients. Each item had a score ranging from 0 to 5 points, with the lowest total score being 0 points and the highest total score being 40 points. The higher the score, the higher the degree of dyspnea.
Measured: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)
CSSAQ is used to assess patients' cough and sputum symptoms. The questionnaire content is based on published literature. It consists of 25 questions, including issues related to cough, sputum, and psychological symptoms and impacts. The scoring uses a four-point Likert scale, with scores ranging from 0 to 4, where higher scores indicate more severe symptoms. The total scale score ranges from a minimum of 0 to a maximum of 100. The content validity index is 1, and the Cronbach's α is 0.97.
Measured: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
Peak Expiratory Flow Rate(PEFR)
The TruZone peak flow meter is used to monitor the patient's Forced Expiratory Volume in the first second (FEV1). For each data collection session, three maximum expiratory flow tests are conducted, and the best value is taken as the result for that session. The measurement unit is ml/sec.
Measured: The study lasted 30 days with a total of three measurements. The first measurement baseline was 48 hours after hospitalization, the second on day 7 of the study, and the third on day 30 of the study.

Secondary outcomes (1)

Re-hospitalization Event
The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.
Measured: Within 14 days after discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 202131 Aug 2021

First posted2 Apr 2021
Study start2 Feb 2021
Primary completion31 Aug 2021
Study completion31 Aug 2021

Why it stopped: Due to the SARS-CoV-2 pandemic in Taiwan in 2021/05, and then recruitment was stopped under the government epidemic prevention policy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary Disease With ExacerbationStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04828837
Sponsor's protocol ID: SYWANG
Status last verified: Oct 2024
First submitted: 25 Feb 2021
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease With Exacerbation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: National Taipei University of Nursing and Heath Sciences
ClinicalTrials.gov ID: NCT04828837
Acronym / sponsor ID: SYWANG
Conditions: Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Pulmonary Disease
Keywords: COPD, Bubble PEP, pulmonary function
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the SARS-CoV-2 pandemic in Taiwan in 2021/05, and then recruitment was stopped under the government epidemic prevention policy.
Enrolment: 57 participants (actual)
Lead sponsor: National Taipei University of Nursing and Health SciencesUniversity, hospital or other
Study start: 2 Feb 2021 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 2 Apr 2021 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Bubble positive expiratory pressure training	Experimental	Device: bubble PEPThe experimental group receives the Bubble PEP training.
general care	No intervention	–The control group receives the division of chest ward routine care.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Hospitalized patients diagnosed with COPD
Over 40 years old
Awareness and ability to read articles
Agree to participate in this research and sign the research consent form

Key exclusion criteria (7 listed)

Use non-invasive positive pressure breathing apparatus
Have received positive pressure breathing therapy before or during hospitalization
People with mental illness
Coughing up blood, pneumothorax
Suffer from legally infectious respiratory diseases

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
bubble PEPUsing the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.	Device	Bubble positive expiratory pressure training

Primary outcome

The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)
Time frame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
In the CAT, a total of eight items were used to assess the degree of dyspnea of the patients. Each item had a score ranging from 0 to 5 points, with the lowest total score being 0 points and the highest total score being 40 points. The higher the score, the higher the degree of dyspnea.
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)
Time frame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.
CSSAQ is used to assess patients' cough and sputum symptoms. The questionnaire content is based on published literature. It consists of 25 questions, including issues related to cough, sputum, and psychological symptoms and impacts. The scoring uses a four-point Likert scale, with scores ranging from 0 to 4, where higher scores indicate more severe symptoms. The total scale score ranges from a minimum of 0 to a maximum of 100. The content validity index is 1, and the Cronbach's α is 0.97.
Peak Expiratory Flow Rate(PEFR)
Time frame: The study lasted 30 days with a total of three measurements. The first measurement baseline was 48 hours after hospitalization, the second on day 7 of the study, and the third on day 30 of the study.
The TruZone peak flow meter is used to monitor the patient's Forced Expiratory Volume in the first second (FEV1). For each data collection session, three maximum expiratory flow tests are conducted, and the best value is taken as the result for that session. The measurement unit is ml/sec.

1 secondary outcome

Re-hospitalization Event
Time frame: Within 14 days after discharge.

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bubble Positive Expiratory Pressure Training	13	8
General Care	14	4

Primary outcome: The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)

Time frame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.. Mean (Standard Deviation). Unit: score on a scale

Measure	General Care Group n = 14	Intervention Group n = 13
T0	13 (6.33)	19.77 (6.26)
T1	11.17 (8.04)	13.18 (10.59)
T2	9.50 (9.26)	9.63 (6.78)

General Care Group vs Intervention Group: Mean Difference (Final Values): 0.39, p <0.05, Wilcoxon (Mann-Whitney)

Population analysed: A total of 57 were randomly assigned and complete test, with 13 in the experimental group and 14 in the control group. At T1, the experimental group had 11 analyzed, experiencing a total loss of 2 participants. In comparison, the control group had 6 analyzed at T1, with a cumulative loss of 8 participants. Moving to T2, the experimental group had 8 analyzed, with a total loss of 3 participants. The control group had 4 analyzed at T2, with a cumulative loss of 2 participants.

Primary outcome: The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)

Measure	Bubble Positive Expiratory Pressure Training n = 13	General Care n = 14
T0	14.38 (10.46)	27.00 (23.31)
T1	23.64 (20.92)	29.83 (28.34)
T2	14.38 (10.46)	27.00 (23.31)

Bubble Positive Expiratory Pressure Training vs General Care: p <0.05, The generalized estimating equation (GEE

Primary outcome: Peak Expiratory Flow Rate(PEFR)

Time frame: The study lasted 30 days with a total of three measurements. The first measurement baseline was 48 hours after hospitalization, the second on day 7 of the study, and the third on day 30 of the study.. Mean (Standard Deviation). Unit: ml/sec

Measure	Bubble Positive Expiratory Pressure Training n = 13	General Care n = 14
T0	320.00 (94.57)	232.50 (85.00)
T1	250.45 (82.60)	273.33 (89.14)
T2	320.00 (94.57)	232.50 (85.00)

Bubble Positive Expiratory Pressure Training vs General Care: p <0.05, The generalized estimating equation (GEE

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bubble Positive Expiratory Pressure Training	0 of 13 (0%)	0 of 13 (0%)	0 of 13
General Care	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): This study was affected by the COVID-19 pandemic. Due to the high attrition rate, our ITT results may have led to over- or underestimation of the effectiveness of the intervention. Sample size should therefore be increased in future studies. In addition, we used self-administered questionnaires for all measures except the PEFR test to evaluate intervention effectiveness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Szu Yi Wang principal investigator

none, specify Unaffiliated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: stopped early, as of the sponsor's last update on 11 Dec 2024. 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 Taiwan. 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?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) (time frame: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04828837.

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 11 Dec 2024.