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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043389
Receipt No. R000049539
Scientific Title A prospective observational study of switching to single-inhaler triple combinations in patients with obstructive pulmonary disease
Date of disclosure of the study information 2021/02/20
Last modified on 2021/02/19

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Basic information
Public title A prospective observational study of switching to single-inhaler triple combinations in patients with obstructive pulmonary disease
Acronym A prospective observational study of switching to single-inhaler triple combinations in patients with obstructive pulmonary disease
Scientific Title A prospective observational study of switching to single-inhaler triple combinations in patients with obstructive pulmonary disease
Scientific Title:Acronym A prospective observational study of switching to single-inhaler triple combinations in patients with obstructive pulmonary disease
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease and bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of switching to single-inhaler triple therapy in patients with COPD or bronchial asthma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes A change of FEV1 after 8 weeks
Key secondary outcomes A change of symptom score, FVC, IC, respiratory impedance, FeNO after 8 weeks

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1. COPD or bronchial asthma patients who are planning to switch to single-inhaler triple therapy
Key exclusion criteria 1. Patients with airway infection within 3 months
2. Patients who are contraindicative for single-inhaler triple therapy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Taisuke
Middle name
Last name Akamatsu
Organization Shizuoka General Hospital
Division name Respiratory medicine
Zip code 420-8527
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
TEL 054-247-6111
Email taisuke-akamatsu@i.shizuoka-pho.jp

Public contact
Name of contact person
1st name Taisuke
Middle name
Last name Akamatsu
Organization Shizuoka General Hospital
Division name Respiratory medicine
Zip code 420-8527
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
TEL 054-247-6111
Homepage URL
Email taisuke-akamatsu@i.shizuoka-pho.jp

Sponsor
Institute Shizuoka General Hospital, respiratory medicine
Institute
Department

Funding Source
Organization none
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 Shizuoka General Hospital IRB
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
Tel 054-247-6111
Email chiken-sougou@shizuoka-pho.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 静岡県立総合病院(静岡県)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 20 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 Open public recruiting
Date of protocol fixation
2020 Year 12 Month 04 Day
Date of IRB
2021 Year 01 Month 15 Day
Anticipated trial start date
2021 Year 02 Month 19 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design (prospective cohort study), Recruitment method of subjects (Patients who visited our facility after Feb 19, 2021, and met the selection criteria), Items to be measured (FEV1, FVC, IC, respiratory impedance, FeNO)

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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