UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037598
Receipt number R000042863
Scientific Title The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination
Date of disclosure of the study information 2019/08/05
Last modified on 2023/11/03 12:50:38

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Basic information

Public title

The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination

Acronym

The effect of switching to single-inhaler triple combination in patients with COPD

Scientific Title

The effect of switching to single-inhaler triple combination in patients with COPD treated with single-inhaler dual combination

Scientific Title:Acronym

The effect of switching to single-inhaler triple combination in patients with COPD

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of switching to single-inhaler triple therapy in patients with symptomatic COPD with characteristic of asthma treated with single-inhaler dual therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

A change of FEV1 after 8 weeks

Key secondary outcomes

A change of symptom score, FVC, IC, respiratory impedance, FeNO after 8 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

One inhalation of a single-inhaler triple combination (fluticasone furoate at a dose of 100 ug, umeclidinium at a dose of 62.5 ug, and vilanterol at a dose of 25 ug) a day

Interventions/Control_2

continuation of dual combination

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. COPD patients who are diagnosed by the criteria of GOLD guideline (FEV1/FVC <0.7)
2. Patients treated with a single-inhaler dual combination (LAMA/LABA or ICS/LABA)
3. Patients with COPD assessment test >=10
4. Patients who are satisfied following criteria
a. Variable or paroxysmal symtoms
b. Documented history of asthma before 40 years of age
c. FeNO>35 ppb
d. Documented history of perennial allergic rhinitis
e. BDR of FEV1 !200 mL and 12% from baseline values
f. Peripheral blood eosinophil count of >300 cells mL
g. high IgE

Key exclusion criteria

1. Patients with airway infection within 3 months
2. Patients under long term oxygen therapy
3. Patients with unstable heart disease
4. Patients who are contraindicative for fluticasone furoate, umeclidinium and vilanterol

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Taisuke
Middle name
Last name Akamatsu

Organization

Shizuoka General Hospital

Division name

respiratory medicine

Zip code

420-8527

Address

4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan

TEL

054-247-6111

Email

taisuke-akamatsu@i.shizuoka-pho.jp


Public contact

Name of contact person

1st name Taisuke
Middle name
Last name Akamatsu

Organization

Shizuoka General Hospital

Division name

respiratory medicine

Zip code

420-8527

Address

4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan

TEL

054-247-6111

Homepage URL


Email

taisuke-akamatsu@i.shizuoka-pho.jp


Sponsor or person

Institute

Shizuoka General Hospital, respiratory medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka General Hospital IRB

Address

4-27-1 Kita Ando Aoi-ku, Shizuoka City, Japan

Tel

054-247-6111

Email

chiken-sougou@shizuoka-pho.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

静岡県立総合病院(静岡県)


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 05 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

Completed

Date of protocol fixation

2019 Year 06 Month 01 Day

Date of IRB

2019 Year 07 Month 29 Day

Anticipated trial start date

2019 Year 08 Month 05 Day

Last follow-up date

2021 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 05 Day

Last modified on

2023 Year 11 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042863


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name