UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054323 |
|---|---|
| Receipt number | R000062058 |
| Scientific Title | The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph. |
| Date of disclosure of the study information | 2024/05/06 |
| Last modified on | 2025/10/31 12:33:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph.
Acronym
The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph.
Scientific Title
The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph.
Scientific Title:Acronym
The study comparing the effects of transitioning from long-acting bronchodilators: beta2 agonists (LABA) (inhaled) and anticholinergics (LAMA) (inhaled) treatment to the addition of inhaled corticosteroids (ICS) in the ICS/LAMA/LABA regimen on the clinical course of COPD, and the additional impact of ICS based on the results from MostGraph.
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we focus on a group of COPD patients with stable symptoms under current treatment, despite experiencing symptoms due to COPD. These patients have been undergoing treatment with a combination of either LAMA/LABA or ICS/LAMA/LABA as their basic therapeutic regimen for three months and are deemed not to require changes in their treatment plan.
Based on previous findings from our facility using IOS, the addition of ICS is believed to increase the ratio of elastic resistance/inertial resistance within airway resistance components. In light of this, the aim is to assess the clinical efficacy of further adding ICS to LAMA/LABA combination therapy.
The study compares the transition from one year of LAMA/LABA therapy to one year of ICS/LAMA/LABA therapy, or from one year of ICS/LAMA/LABA combination therapy to one year of LAMA/LABA therapy. The assessment includes the comparison of IOS, blood tests, symptoms, lung function tests, and detailed progression of COPD exacerbations over one year in the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal changes in IOS (impulse oscillometry system) over a period of one year, including R5 (respiratory system resistance values at 5 Hz) as an index of total airway resistance, R20 (respiratory system resistance values at 20 Hz) as an index of central airway resistance, X5 (reactance at 5 Hz) as an index of frequency-dependent resistance, and Fres (frequency of resonance) as an index of airway resistance components.
Key secondary outcomes
Changes in assessment items commonly used for observing the clinical course of COPD, such as lung function tests and clinical symptoms, before and after LAMA/LABA therapy and ICS/LAMA/LABA therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transition from 12 months of LAMA/LABA treatment to 12 months of ICS/LAMA/LABA treatment.
Interventions/Control_2
Transition from 12 months of ICS/LAMA/LABA treatment to 12 months of LAMA/LABA treatment.
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
On or after July 5, 2022
1. Patients aged 40 and older (both genders)
2. Patients diagnosed with COPD without other coexisting lung diseases at the Department of Respiratory Medicine of Nippon Medical School Hospital or the Respiratory Care Clinic of Nippon Medical School, who are starting either LAMA/LABA treatment or ICS/LAMA/LABA treatment.
Patients who are not expected to require a change in their treatment plan after more than three months of LAMA/LABA treatment or ICS/LAMA/LABA treatment.
Patients who are either current or former smokers, with a lung function FEV1/FVC (forced expiratory volume in one second/forced vital capacity) ratio of <70% and no other diseases associated with airflow obstruction apart from COPD.
Patients who have been provided with an informed consent document and have given consent to participate in this study.
Key exclusion criteria
"Patients with a history of bronchial asthma.
Patients with an increase in FEV1 (forced expiratory volume in one second) of 200 ml or more before and after inhalation of short-acting bronchodilators (400 mcg salbutamol).
Patients with peripheral blood eosinophil counts of 300 cells/uL or more.
Patients with asthma-like symptoms believed to be due to allergic factors.
Patients with a recorded serum IgE level exceeding 170 IU/mL.
Patients already on LAMA, LABA, or ICS therapy outside of this study.
Patients with conditions causing respiratory symptoms other than COPD, such as heart disease leading to congestion.
Patients with angle-closure glaucoma.
Patients with urinary disturbances due to conditions such as prostatic hypertrophy.
Patients with infections for which there are no effective antibiotics or patients with deep-seated fungal infections.
Other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators."
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical school
Division name
Department of Respiratory Mdedicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
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 Respiratory Mdedicine
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
Nippon Medical School
Institute
Department
Personal name
Yosuke Tanaka
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central 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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 06 | 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
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062058
