UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043389 |
|---|---|
| Receipt number | 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 | 2024/02/22 11:19:57 |
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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
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
taisuke-akamatsu@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital, respiratory medicine
Institute
Department
Personal name
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
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
Completed
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
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049539
