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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name