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 2021/05/13 19:49:11

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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

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)

Key secondary outcomes

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.


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

100


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

Email

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


Email

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

Email

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)
日本医科大学千葉北総病院(千葉県)


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

2021 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042394


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name