UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033527 |
|---|---|
| Receipt number | R000038227 |
| Scientific Title | Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD |
| Date of disclosure of the study information | 2018/07/27 |
| Last modified on | 2025/01/29 11:07:46 |
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Basic information
Public title
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD
Acronym
Inhaler use technique and satisfaction with inhaler devices in COPD patients
Scientific Title
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD
Scientific Title:Acronym
Inhaler use technique and satisfaction with inhaler devices in COPD patients
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating inhaler use technique and satisfaction with inhaler devices in Japanese patients with COPD.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with inhaler devices
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Education of inhaler use technique, once
Interventions/Control_2
No education
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. forced expiratory volume% in 1 second under 70%
2. Age over 40
3. Use of inhaler devices (respimat, breezehaler or elipta) for over 3 months
4. Patients with consents informed
Key exclusion criteria
1. Patients with bronchial asthma or other respiratory diseases
2. Patients who can not get an understanding of inhalation technique guidance
3. Patients judged inappropriate as subjects by the principal investigator
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Hospital
Division name
Division of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
satotada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Hospital
Division name
Division of Respiratory Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
satotada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
順天堂大学附属順天堂医院（東京都）、順天堂大学医学部附属浦安病院（千葉県）、済生会川口総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
N/D
Publication of results
Unpublished
Result
URL related to results and publications
N/D
Number of participants that the trial has enrolled
155
Results
PASAPQ scores did not differ between groups. However, Group A showed significantly greater improvement in inhaler technique than Group B (63.3% vs. 27.3%, P < 0.0001). Shorter device use (<13 months) was associated with greater improvement (odds ratio: 9.63, 95% CI: 2.12-43.75), whereas longer device use (>36 months) showed less improvement (odds ratio: 2.11, 95% CI: 0.59-7.60).
Results date posted
| 2025 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included patients diagnosed with COPD who were aged 40 years or older. Participants were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of less than 0.70. Patients were required to have used either Respimat (soft mist inhaler), Breezhaler, or Ellipta (dry powder inhalers) for at least three months, as these inhalers are the most commonly prescribed for COPD patients at Juntendo University Hospital. Patients were excluded if they were unable to understand inhaler instructions or had comorbidities such as heart failure, asthma, idiopathic pulmonary fibrosis, or lung cancer. All participants provided written informed consent.
Participant flow
A total of 151 patients with COPD were considered for inclusion in the study, of whom 25 were excluded due to failure to meet the inclusion criteria (n = 10), treatment discontinuation (n = 7), poor health (n = 6), or inability to undergo respiratory function testing (n = 2). In the final analysis, 126 patients were randomized into two groups: those who received inhaler technique reinstruction (Group A, n = 60) and those who did not (Group B, n = 66). Table 1 shows no significant differences between the groups in age, sex, Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade, inhaler device type, duration of use, or smoking history (pack-years).
Adverse events
None
Outcome measures
The primary endpoint of the study was the total score on the Patient Satisfaction and Preference Questionnaire (PASAPQ) between the intervention and control groups. Secondary endpoints included the COPD Assessment Test (CAT), the modified Medical Research Council (mMRC) dyspnea scale, medication adherence, and respiratory function parameters.
Inhaler satisfaction was measured using the PASAPQ, a 14-item questionnaire that evaluates both the performance and convenience of inhaler devices on a 7-point Likert scale (1 = very dissatisfied, 7 = very satisfied). Medication adherence was assessed using a 5-point self-administered questionnaire, where patients reported how often they missed inhaler doses in the previous two months (1 = never, 5 = five or more days per week missed). Respiratory function was measured using the SYSTEM 21 device (Minato Ikagaku, Osaka, Japan) or the FUDAC-7 device (Fukuda Denshi, Tokyo, Japan).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038227
