UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039722
Receipt No. 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 (Ver. 1)

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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
Email 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
Email eiji.shiwaku@icloud.com

Sponsor
Institute Kyoto-Katsura Hospital, Department of Parmacy
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045191