UMIN-CTR Clinical Trial

Recruitment status	Completed
Unique ID issued by UMIN	UMIN000038453
Receipt No.	R000043789
Scientific Title	Usefulness of inhalation therapy using inhalation support program for hospitalized asthma and COPD patients
Date of disclosure of the study information	2019/10/31
Last modified on	2020/07/09 (Ver. 5)

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Basic information

Public title

Usefulness of inhalation therapy using inhalation support program for hospitalized asthma and COPD patients

Acronym

Usefulness of inhalation therapy using inhalation support program for hospitalized asthma and COPD patients

Scientific Title

Usefulness of inhalation therapy using inhalation support program for hospitalized asthma and COPD patients

Scientific Title:Acronym

Usefulness of inhalation therapy using inhalation support program for hospitalized asthma and COPD patients

Region

Japan

Condition

asthma and COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

Objectives
Narrative objectives1	We will provide inhalation support using our inhalation support program for patients with asthma and COPD in hospital who are being treated with inhaled drugs. We will investigate the usefulness of our in-hospital interventions to improve adherence and quality of life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Degree of comprehension level of understanding of the importance of continuous use 3 months after discharge
Key secondary outcomes	QOL improvement by drug, disease, technique / understanding Adherence improvement by drug, disease, procedure / understanding Improvement of understanding of proper use of inhaled drugs by drug and disease

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Group B (other ward hospitalization group): Intervention based on usual medication guidance will be conducted, and at the time of the first interview and discharge, a questionnaire and ACT, CAT, ASK20 survey will be conducted 3 months after discharge.

Interventions/Control_2

Group A (Respiratory ward hospitalization group): Intervention using an inhalation support program will be conducted, and at the time of first interview and discharge, a questionnaire and ACT, CAT, ASK20 survey will be conducted 3 months after discharge.

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

years-old

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who can use inhaled drugs by themselves
Patients who are judged as asthma or COPD by the attending physician and have a medical record to that effect
Patients who are 16 years of age or older when obtaining consent
Patients who can cooperate in questionnaire surveys at the time of hospitalization and discharge, and 3 months after discharge
Patients who have received sufficient explanation for participation in this study, and have obtained sufficient consent and consent from their own will

Key exclusion criteria

Patients who cannot use inhaled drugs by themselves
Patients with unknown pathological conditions such as asthma and COPD
Patients who are 15 years old or younger at the time of obtaining consent
Patients who cannot cooperate in the questionnaire at the first interview, at the time of discharge, or 3 months after discharge
Patients who cannot obtain their own consent
Other patients who are determined to be inappropriate as research subjects by the principal investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name	Mai
Middle name
Last name	Takahashi

Organization

Mitoyo General Hospital

Division name

Pharmaceutical department

Zip code

769-1695

Address

708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN

TEL

0875-52-3366

Email

shino-ph@mitoyo-hosp.jp

Public contact

Name of contact person

1st name	Hiroshi
Middle name
Last name	Shinonaga

Organization

Mitoyo General Hospital

Division name

Pharmaceutical department

Zip code

769-1695

Address

708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN

TEL

0875-52-3366

Homepage URL

Email

shino-ph@mitoyo-hosp.jp

Sponsor
Institute	Clinical Research Review Committee of Mitoyo General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Review Committee of Mitoyo General Hospital
Address	708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN
Tel	0875-52-3366
Email	shino-ph@mitoyo-hosp.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	三豊総合病院（香川県）

Other administrative information

Date of disclosure of the study information

2019

Year

Month

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

There was a significant increase in the inhalation technique scores on five items at discharge compared to the first time in the intervention group. The mean total ASK score was not significantly different between the intervention and control groups. The mean number of barriers was significantly lower in the intervention group 3 months after discharge than in the first. There was no decrease in the number of barriers in the control group.

Results date posted

2020

Year

Month

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

There were 49 patients in each group who met the selection criteria, and 30 patients in both the intervention and control groups were included in the analysis, excluding dropouts. In the intervention group, there were 8 asthma cases, 20 COPD cases, and 2 Asthma and COPD Overlap cases in the control group, there were 21 asthma cases, 7 COPD cases, and 2 ACO cases. There were 4 and 10 patients in the intervention group and 1 and 0 patients in the control group, respectively, who had a direct cause of asthma or COPD exacerbation in relation to the name of the injury that triggered their admission. The mean length of hospitalization was 12.9days in the intervention group and 17.9days in the control group.

Participant flow

Those who met all of the following selection criteria were eligible for this study. The selection criteria were: (1) the patient was able to use the inhaler by himself, (2) the diagnosis of asthma or COPD was clearly indicated in the medical record, (3) the age at the time of obtaining consent was 16 years or older, (4) the patient was able to complete a questionnaire at the time of admission, discharge, and 3 months after discharge, and (5) the patient was able to obtain written consent. Patients who were not able to collect the questionnaire 3 months after discharge were considered dropouts, and the target number of patients was 30 in each group.
The patients were divided into two groups: those in the respiratory ward (intervention group) and those in other wards (control group). The intervention group received instruction using an inhalation support program in addition to the usual ward drug work, and the control group received the usual ward drug work.
Prior to the study, patients were fully briefed about the study with the consent of their physicians in a written explanation, and oral consent to participate in the study was obtained.

Translated with www.DeepL.com/Translator (free version)

Adverse events

Nothing in particular.

Outcome measures

(1) Inhalation technique
The 10 evaluation items were preparation, orientation of the device, exhalation before inhalation, inhalation movement, breath holding after inhalation, exhalation after inhalation, gargling, control method, dosage, and remaining number of breaths.
(2) QOL
Patients with asthma were assessed using the Asthma Control Test ("ACT") and patients with COPD were assessed using the COPD assessment test ("CAT").
(3) Adherence
The adherence questionnaire (Adherence Starts with Knowledge 20 ("ASK-20") and a questionnaire on understanding of inhalation therapy developed (Figure 1) were used to evaluate the results.

Translated with www.DeepL.com/Translator (free version)

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2017

Year

Month

Day

Date of IRB

2017

Year

Month

Day

Anticipated trial start date

2017

Year

Month

Day

Last follow-up date

2020

Year

Month

Day

Date of closure to data entry

2020

Year

Month

Day

Date trial data considered complete

2020

Year

Month

Day

Date analysis concluded

2020

Year

Month

Day

Other
Other related information

Management information

Registered date

2019

Year

Month

Day

Last modified on

2020

Year

Month

Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043789