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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037192
Receipt No. R000042397
Scientific Title Additive effect of inhaled corticosteroid (ICS) on patients with COPD receiving long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA) single center, real world study
Date of disclosure of the study information 2019/06/27
Last modified on 2020/02/21

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Basic information
Public title Additive effect of inhaled corticosteroid (ICS) on patients with COPD receiving long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA)
single center, real world study
Acronym Additive effect of inhaled corticosteroid (ICS) on patients with COPD receiving long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA)
single center, real world study
Scientific Title Additive effect of inhaled corticosteroid (ICS) on patients with COPD receiving long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA)
single center, real world study
Scientific Title:Acronym Additive effect of inhaled corticosteroid (ICS) on patients with COPD receiving long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA)
single center, real world study
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of inhaled corticosteroid (ICS) add on long acting muscarinic antagonist (LAMA)/long acting beta2 agonist (LABA) in COPD patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Airway resistance investigated with impedance-oscillation system (IOS) to clarify the effect of ICS as add-on to LAMA/LABA on airway lesions in COPD as well as its safety.
Key secondary outcomes Pulmonary function tests, SF36, SGRQ, COPD Assessment Test (CAT), and modified Medical Research Council scores investigated to clarify the effect of ICS as add-on to LAMA/LABA on airway lesions in COPD as well as its safety.

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Included in the study were those in whom LABA (Serevent Rotadisk 50) therapy was replaced with ICS/LABA (Advair Diskus 250/50, fluticasone propionate 250g/salmeterol xinafoate 50 g) therapy after 4 weeks or more of LAMA/LABA therapy (LAMA, tiotropium bromide hydrate as Spiriva Respimat 2.5g; LABA, salmeterol xinafoate as Serevent Rotadisk50); those 40 years old or older diagnosed with COPD; those with a history of smoking or current smokers; those with a FEV1/FVC ratio of less than 70%; and those in whom any disease associated with airflow obstruction other than COPD can be ruled out.
Key exclusion criteria Excluded from the study were those with a documented history of asthma or a bronchodilator response (BDR) to 400g salbutamol shown as a FEV1 change of 200ml or more than 200 mL and those confirmed to have received LAMA, LABA or ICS other than the study drug or their combination.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yosuke
Middle name
Last name Tanaka
Organization Chiba-Hokusoh Hospital, Nippon Medical School
Division name Department of Respiratory Medicine
Zip code 158-0097
Address 1715 Kamagari, Inzai, Chiba 270-1694, Japan.
TEL +81-476-99-1111
Email yosuke-t@nms.ac.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Tanaka
Organization Chiba-Hokusoh Hospital, Nippon Medical School
Division name Department of Respiratory Medicine
Zip code 158-0097
Address 1715 Kamagari, Inzai, Chiba 270-1694, Japan.
TEL +81-476-99-1111
Homepage URL
Email yosuke-t@nms.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department

Funding Source
Organization none
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 Chiba-Hokusoh Hospital, Nippon Medical School
Address The Medical Ethics Committee of Nippon Medical School
Tel +81-476-99-1111
Email araraki@nms.ac.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 日本医科大学千葉北総病院

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 27 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 37
Results
not analysed, yet.
Results date posted
2019 Year 06 Month 27 Day
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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
2018 Year 05 Month 15 Day
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
2025 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information single-center, retrospective, real-world study

Management information
Registered date
2019 Year 06 Month 27 Day
Last modified on
2020 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042397

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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