UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040764 |
|---|---|
| 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 | 2024/10/10 09:58:35 |
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Basic information
Public 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
Acronym
The effect of switching from LAMA / LABA therapy to ICS / LAMA / LABA therapy in patients with COPD. single center, real world study
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
Scientific Title:Acronym
The effect of switching from LAMA / LABA therapy to ICS / LAMA / LABA therapy in patients with COPD. single center, real world study
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in airway pathology one year after adding ICS to LAMA/LABA therapy, as inferred from the results of airway resistance (both expiratory and inspiratory resistance) obtained from impulse oscillation system (IOS) using MostGraph and pulmonary function test.
Key secondary outcomes
modified Medical Research Council (mMRC) Dyspnea Scale scores and study drug safety.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from LAMA/LABA treatment to ICS/LAMA/LABA in COPD patients who have been on long-term LAMA/LABA therapy for over one year and still experience symptoms related to COPD.
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 and Female
Key inclusion criteria
1 Patients aged 40 years or older (both male and female).
2 Patients diagnosed with COPD without other pulmonary diseases at the Respiratory Medicine Department of Nippon Medical School Hospital or Nippon Medical School Respiratory Care Clinic, who had been receiving LAMA/LABA therapy for more than one year, had not experienced any significant COPD exacerbations in the past year, and had stable but persistent COPD symptoms that allowed for daily home activities.
3 Patients who were expected to not require changes to the treatment regimen of ICS/LAMA/LABA therapy for over one year.
4 Patients who were current or former smokers, with lung function showing respiratory system resistance values at 20 Hz in the inspiratory phase: FEV1% (Forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC)) <70%, and without diseases related to airflow obstruction other than COPD.
5 Patients were informed about the study using an informed consent document and provided consent to participate in this study.
Key exclusion criteria
1 Patients with a history of bronchial asthma.
2 Patients who show an increase in FEV1 of 200 ml or more before and after inhalation of a short-acting bronchodilator (400 mcg salbutamol).
3 Patients with a peripheral blood eosinophil count 300 cells/mcL oe more than 300 cells/mcL.
4 Patients with asthma-like symptoms believed to be due to allergic factors.
5 Patients with serum IgE > 170 IU/mL.
6 Patients who have already been treated with any of the drugs LAMA, LABA, or ICS outside of this study.
7 Patients with diseases that cause respiratory symptoms other than COPD, such as heart disease leading to congestion.
8 Patients with closed-angle glaucoma.
9 Patients with urinary retention due to conditions such as prostate hypertrophy.
10 Patients with infections or deep-seated mycoses for which no effective antimicrobial agents are available.
11 Other patients whom the principal investigator or sub-investigator deems unsuitable for participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8603
Address
1-1-5 sendagi, Bunkyo, Tokyo 113-8603, Japan
TEL
03-5814-6266
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
No funding source.
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
the Ethics Committee of Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
03-3822-2131
nms_fuzokurinri@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）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
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.
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042394
