UMIN-CTR Clinical Trial

Public title

Effect of OPEP Therapy on Symptoms and Airway Clearance in Patients With Chronic Cough and Sputum

Acronym

OPEP Airway Clearance Study

Scientific Title

Prospective Observational Study on the Clinical Impact of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients with Chronic Lower Airway Infections and COPD With Sputum Symptoms

Scientific Title:Acronym

OPEP Prospective Observational Study (OPEP-POS)

Region

Japan

Condition

Chronic bronchitis, Bronchiectasis, Non-tuberculous mycobacterial pulmonary disease, Chronic lower airway infection, COPD with chronic sputum symptoms, COPD (chronic obstructive pulmonary disease)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This prospective observational study aims to evaluate the clinical effectiveness of OPEP therapy on symptom improvement in Japanese patients with chronic sputum-producing airway diseases. The primary endpoint is the change in the COPD Assessment Test (CAT) score at 12 weeks. Secondary endpoints include CT mucus plug score, lung function (%FEV1), and sputum culture findings. Factors associated with treatment response will also be explored.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in CAT score at 12 weeks after initiation of OPEP therapy

Key secondary outcomes

CAT responder rate (>= 2-point improvement), Change in CT mucus plug score, Change in %FEV1, Exploratory analysis of predictors of response

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Participants must meet all of the following:
Adults (>=18 years)
Diagnosed with chronic lower airway disease, including: Chronic bronchitis, Bronchiectasis, Non-tuberculous mycobacterial lung disease, COPD with sputum symptoms
Scheduled to start OPEP as part of routine clinical care
CAT score >=10 OR CAT 7-9 with sputum item score >=3
Able to provide written informed consent
Baseline assessments available within protocol-defined time windows

Key exclusion criteria

Acute exacerbation within the past 4 weeks
Severe cardiac or cognitive conditions that preclude valid evaluation
Contraindications to safe OPEP use (e.g., current pneumothorax)
Withdrawal of consent before data lock
Inability to ensure clinical stability at the evaluation timepoint

Target sample size

70

Name of lead principal investigator

1st name	Hirotoshi
Middle name
Last name	Yasui

Organization

Toyohashi Municipal Hospital

Division name

Department of Respiratory Medicine

Zip code

441-8570

Address

50, Hachiken-Nishi, Aotake, Toyohashi, Aichi

TEL

0532336111

Email

yasui-hirotoshi@toyohashi-mh.jp

Name of contact person

1st name	Hirotoshi
Middle name
Last name	Yasui

Organization

Toyohashi Municipal Hospital

Division name

Department of Respiratory Medicine

Zip code

441-8570

Address

50, Hachiken-Nishi, Aotake, Toyohashi, Aichi

TEL

0532336111

Homepage URL

Email

yasui-hirotoshi@toyohashi-mh.jp

Institute

Hirotoshi Yasui, M.D.
Department of Respiratory Medicine
Toyohashi Municipal Hospital

Institute

Department

Personal name

Hirotoshi Yasui

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Toyohashi Municipal Hospital

Address

50, Hachiken-Nishi, Aotake

Tel

0532336111

Email

yasui-hirotoshi@toyohashi-mh.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

豊橋市民病院（愛知県）

Date of disclosure of the study information

2025

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

12

Month

03

Day

Date of IRB

Anticipated trial start date

2025

Year

12

Month

10

Day

Last follow-up date

2027

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a prospective observational study in patients who initiate Oscillatory Positive Expiratory Pressure (OPEP) therapy as part of routine clinical care. No additional interventions or tests are performed for research purposes. Clinical data obtained during usual care are used for analysis. Observed variables include baseline assessments (CAT score, chest CT mucus plug score, pulmonary function tests, and sputum culture results) and follow-up assessments at 12 (+-4) weeks after initiation of OPEP therapy. The primary objective is to evaluate the change in CAT score before and after OPEP therapy. Secondary observations include changes in CT findings and lung function. All evaluations are conducted at clinically scheduled visits, and no additional visits or procedures are required for the study.

Registered date

2025

Year

11

Month

19

Day

Last modified on

2025

Year

11

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068381