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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024905
Receipt No. R000028656
Scientific Title A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation
Date of disclosure of the study information 2016/11/21
Last modified on 2018/09/07

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Basic information
Public title A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation
Acronym COPD and eosinophilic inflammation.
Scientific Title A randomized, open-label, crossover study to evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation
Scientific Title:Acronym COPD and eosinophilic inflammation.
Region
Japan

Condition
Condition COPD
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate ICS/LABA treatment versus LAMA/LABA treatment in COPD with eosinophilic inflammation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FEV1 after 4 weeks of treatment.
Key secondary outcomes Dyspnoea, symptoms, FENO level, and blood eosinophils after 4 weeks of treatment. Adverse events and exacerbation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with ICS/LABA for 4 weeks, then treatment with LAMA/LABA for 4 weeks.
Interventions/Control_2 Treatment with LAMA/LABA for 4 weeks, then tteatment with ICS/LABA for 4 weeks.
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 Severity of airflow limitation as GOLD 2-4; have a smoking history of at least 10 pack-years; and FENO level of at least 25 ppb.
Key exclusion criteria Asthma overlap (ACOS); history of lung resection; using inhaled or oral corticosteroid; receiving anti-IgE therapy; and exacerbation of COPD in the 4 weeks.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Kobayashi
Organization Japanese Red Cross Ishinomaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Email skoba-thk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Kobayashi
Organization Japanese Red Cross Ishinomaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL 0225-21-7220
Homepage URL
Email skoba-thk@umin.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Japanese Red Cross Ishinomaki Hospital
Institute
Department

Funding Source
Organization NON
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
Address
Tel
Email

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 石巻赤十字病院

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 21 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 Terminated
Date of protocol fixation
2016 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 21 Day
Last follow-up date
2018 Year 09 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 19 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028656

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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