UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039722 |
|---|---|
| Receipt number | R000045191 |
| Scientific Title | Benefits of pharmacist-led inhaler choice for lung function in patients with chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2020/03/06 08:22:29 |
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Basic information
Public title
Benefits of pharmacist-led inhaler choice for lung function in patients with chronic obstructive pulmonary disease
Acronym
Benefits of pharmacist-led inhaler choice for lung function in patients with chronic obstructive pulmonary disease
Scientific Title
Benefits of pharmacist-led inhaler choice for lung function in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym
Benefits of pharmacist-led inhaler choice for lung function in patients with chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the impact of pharmacist-led inhaler choice on lung function in patients with COPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was the change in FEV1 between baseline and the end of the study period at 26 weeks.
Key secondary outcomes
The secondary endpoints were safety and the changes in the scores for the three scales, which was the COPD Assessment Test (CAT) ,the modified British Medical Research Council Dyspnoea Scale (mMRC), Adherence Starts with Knowledge-20 (ASK-20).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After receiving a diagnosis of COPD that indicated inhaler therapy, the patient was immediately interviewed by the pharmacist, who assessed the patient's ability to use an inhaler considering factors such as inhalation, grip and hearing and his or her understanding of what is required, as well as the patient's expectations and preferences, and practical considerations such as device portability, the need for visual and auditory confirmation of successful inhalation, daily dose frequency and medication cost.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients were those with stable COPD, defined as the presence of a post-bronchodilator forced expiratory volume in 1 s (FEV1) of <70% and confirmation from the physician that they were clinically stable.
Key exclusion criteria
The study excluded any patients who had undergone pneumonectomy or who had dementia and could not be provided with caregiving support for inhaler therapy.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Dote |
Organization
Kyoto-Katsura Hospital
Division name
Department of Pharmacy
Zip code
615-8256
Address
Yamadahirao-cho 17, Nishikyo-ku, Kyoto city, Kyoto
TEL
075-391-5811
jah-yah@hotmail.co.jp
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
Yamadahirao-cho 17, Nishikyo-ku, Kyoto city, Kyoto
TEL
075-391-5811
Homepage URL
eiji.shiwaku@icloud.com
Sponsor or person
Institute
Kyoto-Katsura Hospital, Department of Parmacy
Institute
Department
Personal name
Funding Source
Organization
Kyoto-Katsura Hospital, Department of Parmacy
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
Kyoto-Katsura Hospital
Address
Yamadahirao-cho 17, Nishikyo-ku, Kyoto city, Kyoto
Tel
075-391-5811
chiken@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
京都桂病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://1drv.ms/w/s!AtV0XL_8OJ6JbGvbUWqi529dJSY?e=xCfaHk
Publication of results
Unpublished
Result
URL related to results and publications
https://1drv.ms/b/s!AtV0XL_8OJ6Jcp_oRG5Z90ABt7k?e=Zj6gdu
Number of participants that the trial has enrolled
48
Results
The pharmacist-led inhaler choice group showed a significantly greater improvement in FEV1 from baseline to the end of the study than the physician-led inhaler choice group (0.38 L vs. 0.24 L, p = 0.02) . A subgroup analysis of the change in FEV1 for each drug class showed that the improvement was greater for the pharmacist-led inhaler choice group in all cases.
Results date posted
| 2020 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients background was 72 years old, male 83.3%, weight 59.9 kg, trough FEV1(baseline):1.60 L, Performance status 0/1/2/3: 71.7% / 21.7% /3.3%/3.3%. The clinical stage of COPD was Stage I / II / III / IV: 15% / 55.0% / 28.3% / 1.7%.
Participant flow
From April 1,2016 to March 31,2018,60 patients were diagnosed with stable COPD and started new inhalation therapy.Exclusion criteria was patients who received a second opinion but were not referred to our hospital(6),died(4),and pneumonectomy(2).At 26 weeks,48 patients undergoing lung function test was analyzed.
Adverse events
Adverse events were experienced by eight (13%) of the initial 60 patients in the pharmacist-led inhaler choice group, as follows: dry mouth (4 patients, 7%), hoarseness (3 patients, 5%) and ischuria (one patient, 2%).
Outcome measures
The study period for each patient was 26 weeks from the commencement of inhaler use (baseline). Prior to this, the patient's FEV1 was measured and his or her status was assessed using three scales (COPD Assessment Test, modified British Medical Research Council Dyspnoea Scale, Adherence Starts with Knowledge20).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045191
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