UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021086
Receipt number R000024324
Scientific Title A comparison of the additive efficacy of Umeclidinium bromide on fluticasone furoate/vilanterole in asthma-COPD overlap syndrome.
Date of disclosure of the study information 2016/03/01
Last modified on 2017/02/23 15:56:56

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Basic information

Public title

A comparison of the additive efficacy of Umeclidinium bromide on fluticasone furoate/vilanterole in asthma-COPD overlap syndrome.

Acronym

Additive effect of Umeclidinium bromide on fluticasone furoate/vilanterole in asthma-COPD overlap syndrome.

Scientific Title

A comparison of the additive efficacy of Umeclidinium bromide on fluticasone furoate/vilanterole in asthma-COPD overlap syndrome.

Scientific Title:Acronym

Additive effect of Umeclidinium bromide on fluticasone furoate/vilanterole in asthma-COPD overlap syndrome.

Region

Japan


Condition

Condition

asthma-COPD overlap syndrome

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the additive effect of Umeclidinium bromide on fluticasone furoate/vilanterole in patients with asthma-COPD overlap syndrome

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvement of respiratory functions

Key secondary outcomes

Improvement of quality of life


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

Additive admionistration of Umeclidinium bromide on fluticasone furoate/vilanterole in patients with asthma-COPD overlap syndrome
Patients are divided in 2 groups. In group A, firstly 4 week treatment of Umeclidinium bromide and fluticasone furoate/vilanterole, next 4 weeks only fluticasone furoate/vilanterole. In B group, firstly 4 week treatment of only fluticasone furoate/vilanterole, next 4 weeks Umeclidinium bromide and fluticasone furoate/vilanterole are administered. Respiratory functions and were evalueted before and each treatment periods.

Interventions/Control_2

Additive admionistration of Umeclidinium bromide on fluticasone furoate/vilanterole in patients with asthma-COPD overlap syndrome
Patients are divided in 2 groups. In group A, firstly 4 week treatment of Umeclidinium bromide and fluticasone furoate/vilanterole, next 4 weeks only fluticasone furoate/vilanterole. In B group, firstly 4 week treatment of only fluticasone furoate/vilanterole, next 4 weeks Umeclidinium bromide and fluticasone furoate/vilanterole are administered. QOL scores are evalueted before and each treatment periods.

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

16 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

stable asthma-COPD overlap syndrome

Key exclusion criteria

unstable asthma-COPD overlap syndrome

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihisa Ishiura

Organization

Toyama City Hospital

Division name

Respiratory Medicine

Zip code


Address

2-1 Imaizumi-Hokubu-machi, Toyama City Toyama, Jappan

TEL

076-422-1112

Email

ishiura@tch.toyama.toyama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihisa Ishiura

Organization

Toyama City Hospital

Division name

Respiratory Medicine

Zip code


Address

2-1 Imaizumi-Hokubu-machi, Toyama City Toyama, Jappan

TEL

076-422-1112

Homepage URL


Email

ishiura@tch.toyama.toyama.jp


Sponsor or person

Institute

Respiratory Medicine of Toyama City Hospital

Institute

Department

Personal name



Funding Source

Organization

Respiratory Medicine of Toyama City Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 01 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

2016 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 18 Day

Last modified on

2017 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024324


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name