Unique ID issued by UMIN | UMIN000037598 |
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Receipt number | R000042863 |
Scientific Title | The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination |
Date of disclosure of the study information | 2019/08/05 |
Last modified on | 2023/11/03 12:50:38 |
The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination
The effect of switching to single-inhaler triple combination in patients with COPD
The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination
The effect of switching to single-inhaler triple combination in patients with COPD
Japan |
Chronic obstructive pulmonary disease
Pneumology |
Others
NO
To investigate the effect of switching to single-inhaler triple therapy in patients with symptomatic COPD with characteristic of asthma treated with single-inhaler dual therapy
Efficacy
Confirmatory
Pragmatic
Not applicable
A change of FEV1 after 8 weeks
A change of symptom score, FVC, IC, respiratory impedance, FeNO after 8 weeks
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Medicine |
One inhalation of a single-inhaler triple combination (fluticasone furoate at a dose of 100 ug, umeclidinium at a dose of 62.5 ug, and vilanterol at a dose of 25 ug) a day
continuation of dual combination
40 | years-old | <= |
Not applicable |
Male and Female
1. COPD patients who are diagnosed by the criteria of GOLD guideline (FEV1/FVC <0.7)
2. Patients treated with a single-inhaler dual combination (LAMA/LABA or ICS/LABA)
3. Patients with COPD assessment test >=10
4. Patients who are satisfied following criteria
a. Variable or paroxysmal symtoms
b. Documented history of asthma before 40 years of age
c. FeNO>35 ppb
d. Documented history of perennial allergic rhinitis
e. BDR of FEV1 !200 mL and 12% from baseline values
f. Peripheral blood eosinophil count of >300 cells mL
g. high IgE
1. Patients with airway infection within 3 months
2. Patients under long term oxygen therapy
3. Patients with unstable heart disease
4. Patients who are contraindicative for fluticasone furoate, umeclidinium and vilanterol
70
1st name | Taisuke |
Middle name | |
Last name | Akamatsu |
Shizuoka General Hospital
respiratory medicine
420-8527
4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
054-247-6111
taisuke-akamatsu@i.shizuoka-pho.jp
1st name | Taisuke |
Middle name | |
Last name | Akamatsu |
Shizuoka General Hospital
respiratory medicine
420-8527
4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
054-247-6111
taisuke-akamatsu@i.shizuoka-pho.jp
Shizuoka General Hospital, respiratory medicine
none
Self funding
Shizuoka General Hospital IRB
4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan
054-247-6111
chiken-sougou@shizuoka-pho.jp
NO
静岡県立総合病院(静岡県)
2019 | Year | 08 | Month | 05 | Day |
Unpublished
Completed
2019 | Year | 06 | Month | 01 | Day |
2019 | Year | 07 | Month | 29 | Day |
2019 | Year | 08 | Month | 05 | Day |
2021 | Year | 07 | Month | 31 | Day |
2019 | Year | 08 | Month | 05 | Day |
2023 | Year | 11 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042863
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