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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041250
Receipt No. R000047101
Scientific Title Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Date of disclosure of the study information 2020/08/06
Last modified on 2020/08/14

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Basic information
Public title Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Acronym EPT-study
Scientific Title Efficacy and applicability of expiratory pressure load training in patients with chronic obstructive pulmonary disease: a multicenter, randomized controlled trial
Scientific Title:Acronym EPT-study
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of expiratory pressure load training (EPT) for 12 weeks 1) in patients with severe and very severe chronic obstructive pulmonary disease (COPD) using confirmatory analyses; 2) in patients with mild to moderate COPD using searching analyses; and 3) to show how EPT confers these benefits, if any, a multicenter, randomized controlled trial was conducted.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endurance time, which will be evaluated by constant work rate exercise test during cardiopulmonary exercise testing (CPET) in patients with severe and very severe COPD.
Key secondary outcomes 1. Endurance time, which will be evaluated by constant work rate exercise test during CPET in patients with mild and moderate COPD.
2. In patients with severe and very severe COPD, or with mild and moderate COPD:
i) Symptom (SGRQ score: Total domain, Symptom, Activity, Impact)
ii) Respiratory function (RV, RV/TLC)
iii) During CPET, which will consist of incremental exercise test or constant work rate exercise test, the parameters: oxygen uptake (VO2), minute ventilation (VE), ventilatory equivalent, physiologic dead space/tidal volume ratio (VD/VT), expiratory tidal volume (VTex), mean expiratory flow (VTex/Te), inspiratory tidal volume (VTin), VTin-VTex, ratio of inspiratory time to total respiratory cycle time (Ti/Ttot) dyspnea (Borg scale), and collapse ratio of vocal cords using laryngeal scope, will be evaluated during exercise.
iv) Respiratory muscle pressure: maximum expiratory pressure (MEP)
v) 6-minute walk test: 6-minute walk distance
vi) Oxygen saturation of peripheral artery (SpO2) during the night

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients who meet the eligibility criteria will be enrolled and randomly assigned in a 1:1 ratio to be classified into the EPT group or the control group. In addition, patients in both groups will be classified to indicate the disease stage in equal populations. In the EPT group, the patients will receive EPT 30 times twice per day for 3 months. The load of EPT will be started at 20% of the maximum expiratory pressure obtained at baseline and can be increased once every 2 weeks to up to 50% of the maximum pressure.
Interventions/Control_2 The control group will not receive the intervention by EPT.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with moderate to very severe COPD (FEV1/FVC < 70%, i.e., Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification airflow limitation severity, from I to IV)
2) Patients whose conditions are stable and who are able to tolerate cardiopulmonary exercise testing to ensure adequate evaluation
3) Patients who have signed the agreement for participation in this study
Key exclusion criteria 1) Patients with malignant tumors
2) Patients with active infection
3) Patients with severe heart disease
4) Patients with asthma
5) Patients whose drug regimen was changed during this study
6) Patients who are receiving pulmonary rehabilitation
7) Patients who receive oxygen therapy during exercise
8) Patients with a history of pneumothorax or who have a giant bulla with a high risk of developing pneumothorax
9) In addition to the above exclusion criteria, patients judged by their physician to be ineligible to participate in this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Miki
Organization National Hospital Organization
Osaka Toneyama Medical Center
Division name Department of Respiratory Medicine
Zip code 560-8552
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL 0668532001
Email miki.keisuke.pu@mail.hosp.go.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Miki
Organization National Hospital Organization Osaka Toneyama Medical Center
Division name Department of Respiratory Medicine
Zip code 560-8552
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
TEL +81668532001
Homepage URL
Email miki.keisuke.pu@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Osaka Toneyama Medical Center
Institute
Department

Funding Source
Organization Grant-in-Aid for Clinical Research from National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Respiratory Disease Center, Kitano Hospital, Tazuke Kofukai Medical Research Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Osaka Toneyama Medical Center
Address 5-1-1 Toneyama, Toyonaka, Osaka, 560-8552, Japan
Tel 0668532001
Email 410-chiken@mail.hosp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 06 Month 22 Day
Date of IRB
2020 Year 07 Month 27 Day
Anticipated trial start date
2020 Year 08 Month 14 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 29 Day
Last modified on
2020 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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