UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052218 |
|---|---|
| Receipt number | R000059529 |
| Scientific Title | A randomized controlled trial of community pharmacist-led inhaler choice for improvement of lung function in patient with COPD |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/09/17 09:51:34 |
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Basic information
Public title
Community pharmacist-led inhaler choice for improvement of lung function in COPD
Acronym
CYCLE study
Scientific Title
A randomized controlled trial of community pharmacist-led inhaler choice for improvement of lung function in patient with COPD
Scientific Title:Acronym
CYCLE study
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study aim is to investigate improvement of lung function with community pharmacist-led inhaler choice in COPD patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of FEV1 (Forced Expiratory Volume 1 second) from baseline to week 24
Key secondary outcomes
Forced Vital Capacity (FVC), Inspiratory Capacity (IC), COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) Dyspnea Scale, EuroQol 5 dimensions (EQ-5D), Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patient
-Watch the educational video with COPD and its medication.
Community pharmacist
1) Measure peak inspiratory flow rate using Clement Clarke In-Check DIAL G16.
2) Counsell and choice personalized inhaler based on originally developed inhaler choice protocol installed on iPad.
3) Recommend pharmacist-choiced inhaler to pulmonologist if prescribed inhaler does not match pharmacist-choiced inhaler.
4) Give inhalation instruction and demonstration of finally prescribed inhaler.
Interventions/Control_2
Patient
-Watch the educational video with COPD and its medication.
Community pharmacist
-Give inhalation instruction and demonstration of prescribed inhaler.
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
Outpatients with newly diagnosed COPD indicating inhaler therapy
Key exclusion criteria
Stage IV (%FEV1<30%)
Dementia
Prognosis is predicted within one year
Overlap with bronchial asthma
Informed consent is not obtained
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shiwaku |
Organization
Kyoto-Katsura Hospital
Division name
Department of Pharmacy
Zip code
615-8256
Address
Kyoto-shi, Nishikyo-ku, Yamadahiraocho, 17
TEL
075-392-1609
shiwaku.eiji@katsura.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shiwaku |
Organization
Kyoto-Katsura Hospital
Division name
Department of Pharmacy
Zip code
615-8256
Address
Kyoto-shi, Nishikyo-ku, Yamadahiraocho, 17
TEL
075-392-1609
Homepage URL
shiwaku.eiji@katsura.com
Sponsor or person
Institute
Eiji Shiwaku, Department of Pharmacy, Kyoto-Katsura Hospital.
Institute
Department
Personal name
Funding Source
Organization
The Research Foundation for Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyoto-Katsura Hospital
Address
Kyoto-shi, Nishikyo-ku, Yamadahiraocho, 17
Tel
075-392-1609
noriko.fujita@katsura.com
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
| 2023 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 09 | Month | 15 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059529
