Unique ID issued by UMIN | UMIN000040764 |
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Receipt number | R000042394 |
Scientific Title | Evaluation of the effect of switching from LAMA / LABA therapy to ICS-containing triple therapy (ICS/LAMA/LABA) in patients with COPD. single center, real world study |
Date of disclosure of the study information | 2020/06/15 |
Last modified on | 2021/05/13 19:49:11 |
Evaluation of the effect of switching from LAMA / LABA therapy to ICS-containing triple therapy (ICS/LAMA/LABA) in patients with COPD. single center, real world study
The effect of switching from LAMA / LABA therapy to ICS / LAMA / LABA therapy in patients with COPD. single center, real world study
Evaluation of the effect of switching from LAMA / LABA therapy to ICS-containing triple therapy (ICS/LAMA/LABA) in patients with COPD. single center, real world study
The effect of switching from LAMA / LABA therapy to ICS / LAMA / LABA therapy in patients with COPD. single center, real world study
Japan |
Chronic obstructive pulmonary disease
Pneumology |
Others
NO
To evaluate the efficacy of inhaled corticosteroid (ICS) as add-on to long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) in COPD patients.
Efficacy
Confirmatory
Not applicable
The change in airway pathology, i.e., change in FEV1 at week 4 on spirometry and respiratory resistance (both expiratory and inspiratory resistance) using a MOST graph on impulse oscillometry (IOS)
COPD Assessment Test (CAT) scores, modified Medical Research Council (mMRC) Dyspnea Scale scores, St. George's Respiratory Questionnaire (SGRQ) scores, Short Form (36) Health Survey (SF-36) scores, and study drug safety.
Observational
40 | years-old | <= |
Not applicable |
Male and Female
Included in the study were those in whom ICS added on after 4 weeks or more of long acting bronchodilator therapy(LABA therapy and LAMA therapy)
; those 40 years old or older diagnosed with COPD; past or current smokers with COPD; 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.
Excluded from the study were those with a documented history of asthma, a bronchodilator response (BDR) to 400 microgram salbutamol shown as a FEV1 change of and or more than 200 ml or peripheral eosinophilia more than 150, presence of typical asthma symptoms of atopy or history of IgE more than 170IU/ml and those confirmed to have received LAMA, LABA or ICS other than the study drug or their combination.
100
1st name | Yosuke |
Middle name | |
Last name | Tanaka |
Nippon Medical School Hospital
Department of Respiratory Medicine
113-8603
1-1-5 sendagi, Bunkyo, Tokyo 113-8603, Japan
03-5814-6266
yosuke-t@nms.ac.jp
1st name | Yosuke |
Middle name | |
Last name | Tanaka |
Nippon Medical School
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
113-8603
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
yosuke-t@nms.ac.jp
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School
No funding source.
Other
the Ethics Committee of Nippon Medical School
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
03-3822-2131
nms_fuzokurinri@nms.ac.jp
NO
日本医科大学付属病院(東京都)
日本医科大学呼吸ケアクリニック(東京都)
日本医科大学千葉北総病院(千葉県)
2020 | Year | 06 | Month | 15 | Day |
Unpublished
Open public recruiting
2011 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2025 | Year | 07 | Month | 31 | Day |
2025 | Year | 07 | Month | 31 | Day |
2025 | Year | 06 | Month | 30 | Day |
All eligible patients receiving LAMA/LABA were evaluated for all relevant parameters from 1 week before the day on which they had been switched from LAMA/LABA to LAMA/LABA/ICS until more than 4 but less than 5 weeks after switching.
2020 | Year | 06 | Month | 15 | Day |
2021 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042394
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