UMIN-CTR Clinical Trial

Basic information
Public title	The characteristics of patients and breathing causing dynamic pulmonary hyperinflation, a factor in dyspnea in chronic obstructive pulmonary disease; a retrospective study.
Acronym	The characteristics of patients and breathing causing dynamic pulmonary hyperinflation.
Scientific Title	The characteristics of patients and breathing causing dynamic pulmonary hyperinflation, a factor in dyspnea in chronic obstructive pulmonary disease; a retrospective study.
Scientific Title:Acronym	The characteristics of patients and breathing causing dynamic pulmonary hyperinflation.
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease
Classification by specialty	Pneumology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine the characteristics of COPD patients causing dynamic lung hyperinflation in hyperventilation method.
Basic objectives2	Others
Basic objectives -Others	The purpose of this study is to determine the threshold for dynamic lung hyperinflation limiting exercise in hyperventilation method.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The decrease of the inspiratory capacity after 20, 30, and 40 bpm of hyperventilations relative to the inspiratory capacity at rest, as a index of dynamic pulmonary hyperinflation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	COPD patients Patients aged 20 years or older diagnosed with chronic obstructive pulmonary disease (Guidelines for the Diagnosis and Treatment of COPD, 4th Edition, Japanese Respiratory Society) Patients who visited Shinshu University Hospital for diagnosis and treatment of COPD. Patients who have given written consent for participation and enrollment in clinical research. Healthy volunteers Healthy subjects over 18 years of age without respiratory disease or respiratory dysfunction. Outpatients with diseases other than COPD, such as sleep apnea syndrome, who has normal respiratory function. Persons who have given written consent for participation and enrollment in the clinical study.
Key exclusion criteria	Persons with heart failure. Patients with exacerbations or respiratory infections within 3 months. Patients with serious cardiac disease or arrhythmia. Patients who have difficulty in walking due to motor or cognitive dysfunction. Patients on long-term oxygen therapy.
Target sample size	174

Research contact person
Name of lead principal investigator	1st name Shohei Middle name Last name Kawachi
Organization	Nagoya University
Division name	Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code	461-0047
Address	1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673, Japan
TEL	052-719-1365
Email	kawachi@met.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Shohei Middle name Last name Kawachi
Organization	Nagoya University
Division name	Department of Integrated Health Sciences Nagoya University Graduate School of Medicine
Zip code	461-0047
Address	1-1-20 Daiko-minami, Higashi-ku, Nagoya 461-8673, Japan
TEL	052-719-1365
Homepage URL
Email	kawachi@met.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya
Tel	052-744-2973
Email	ethics@med.nagoya-u.ac.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	2022 Year 08 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date	2022 Year 08 Month 24 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The purpose of this study is to determine the characteristics of COPD patients occuring dynamic lung hyperinflation and the threshold for dynamic lung hyperinflation that limits exercise in heperventilatiuon methods. According to the classification of severity of airflow obstruction, COPD patients will be classified into 4 groups (mild, moderate, severe, and very severe airflow obstruction) based on the results of %FEV1, and the primary outcome will be compared between the 5 groups, including a healthy volunteer group. Furthermore, to characterize COPD patients who develop dynamic lung hyperinflation early in exercise, patients will be classified into three groups: one group that occur dynamic lung hyperinflation exceeding the clinically minimum important difference (MID) after 20 bpm of hyperventilation, one group that occur dynamic lung hyperinflation exceeding MID after 30 bpm pf hyperventilation, and one group that occur dynamic lung hyperinflation exceeding MID after 40 bpm pf hyperventilation. Secondary outcome will be comared between those three groups.

Management information
Registered date	2022 Year 07 Month 14 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055131