UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037192 |
|---|---|
| Receipt number | 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 08:52:59 |
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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
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
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042397
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| Registered date | File name |
| Research case data | |
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