UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045239 |
|---|---|
| Receipt number | R000051679 |
| Scientific Title | Analysis of Response Shifts in Patient-Reported Indicators Using the SGRQ-C to Determine the Effectiveness of Drug Therapy in COPD Patients |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2021/08/24 13:16:08 |
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Basic information
Public title
Analysis of Response Shifts in Patient-Reported Indicators for Determining Drug Treatment Effectiveness in COPD Patients
Acronym
Effect of Subjective Evaluation on Subjective Symptom Score in Determining the Effectiveness of Inhalation Therapy in COPD Patients
Scientific Title
Analysis of Response Shifts in Patient-Reported Indicators Using the SGRQ-C to Determine the Effectiveness of Drug Therapy in COPD Patients
Scientific Title:Acronym
Response Shift Analysis of Quality of Life Indicators in Determining Treatment Effectiveness in COPD Patients
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In large clinical trials to date, bronchodilators have significantly improved respiratory function in patients with COPD, but patient-reported measures such as dyspnea and quality of life often fail to reach MCID (minimum clinically meaningful change), even though they are statistically significant. We feel that there is a discrepancy with the beneficial effects we experience in clinical practice. We hypothesized that this discrepancy may be due to the response shift phenomenon. We hypothesized that the standard axis for judging subjective indices such as dyspnea and QOL before and after bronchodilator treatment has changed, and that the difference is underestimated in a mere before/after comparison. We thought that this would allow us to evaluate the effect more accurately. We decided to reevaluate the pre-treatment status of COPD patients after treatment and compare it with the status originally assessed before treatment. In this study, we will evaluate respiratory function tests and the Japanese version of CAT (COPD Assessment Test), the Japanese version of SGRQ-C (COPD-specific St. George's Respiratory Questionnaire), and the Japanese version of SGRQ-C (COPD-specific Quality of Life Questionnaire) in COPD patients before and after treatment intervention.
Basic objectives2
Others
Basic objectives -Others
Changes in Quality of Life Indices in COPD Patients at the Beginning of Therapeutic Intervention or Before and After Intensified Treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SGRQ-C(COPD-specific St. George's Respiratory Questionnaire)
Key secondary outcomes
CAT (COPD Assessment Test)
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age 20 years and older
Patients who are symptomatic and about to start initial or additional treatment with long-acting bronchodilators for COPD
Smoking history of more than 20 pack-years
Meet the diagnostic criteria for COPD (Japanese Respiratory Society Guidelines, 5th Edition)
No change in treatment in the last 2 months
No exacerbation of COPD in the last 6 weeks
Key exclusion criteria
Poorly controlled comorbidities
Dementia
Writing difficulties
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shonosuke |
| Middle name | |
| Last name | Tajima |
Organization
Kawasaki medical school
Division name
Respiratory medicine
Zip code
701-0192
Address
577Matsushima,Kurashiki city,Okayama pref.
TEL
086-462-1111
shonosuke@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Shonosuke |
| Middle name | |
| Last name | Tajima |
Organization
Kawasaki medical school
Division name
Respiratory medicine
Zip code
701-0192
Address
577Matsushima,Kurashiki city,Okayama pref.
TEL
086-462-1111
Homepage URL
shonosuke@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki medical school Ethical Committee
Address
577Matsushima,Kurashiki city,Okayama pref.
Tel
086-464-1076
Kmsrec@med.kawasaki-m.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
川崎医科大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051679
