UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010276
Receipt number R000010664
Scientific Title The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction.
Date of disclosure of the study information 2013/03/19
Last modified on 2019/03/24 22:40:51

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Basic information

Public title

The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction.

Acronym

Evaluation of Salmeterol/ Fluticasone propionate compound effecacy in chronic obstructive pulmonary disease.

Scientific Title

The study of predictive factors for the effect of Salmeterol/Fluticasone combination(SFC) on the patients with obstructive pulmonary dysfunction.

Scientific Title:Acronym

Evaluation of Salmeterol/ Fluticasone propionate compound effecacy in chronic obstructive pulmonary disease.

Region

Japan


Condition

Condition

obstructive pulmonary dysfunction

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the predictive factors for the effect of salmeterol / fluticasone combination agent on patients with obstructive pulmonary dysfunction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

FEV1

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

salmeterol/fulticasone propionate combination

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) FEV1/FVC< 70% pre-bronchodilator
2) Age 40-75 y.o.
3) possible observe for 4wks
4) consent in writing

Key exclusion criteria

1) medication of corticosteroid in 4wks
2) medication of anticholinergic drug in 4wks
3) medication of long acting beta agonist in 4 wks
4) inhalation of short acting beta agonist in 6hrs
5) patients who has heart failure, severe arrhythmia.
6) medication of beta blocker
7) active infectious disease and tuberculous disease
8) pationts who had resected lung
9) psycosomatic patients
10) allergy for SFC
11) difficult to do spirometry
12) pregnancy
13) diagnosis for other pulmonary disease

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiromasa
Middle name
Last name INOUE

Organization

Kagoshima university

Division name

Pulmonary medicine

Zip code

8908570

Address

8-35-1Sakuragaoka Kagoshima city, Japan

TEL

099-275-6481

Email

ikkou@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name MACHIDA

Organization

Kagoshima university

Division name

pulmonary medicine

Zip code

8908570

Address

8-35-1Sakuragaoka Kagoshima city, Japan

TEL

0992756481

Homepage URL


Email

machida@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima university pulmonary medicine

Institute

Department

Personal name



Funding Source

Organization

kagoshima university pulmonary medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kurume university
Tokai university

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima university

Address

sakuragaoka 8-35-1, Kagoshima City

Tel

0992756481

Email

machida@m.kufm.kagoshima-u.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

鹿児島大学病院(鹿児島県) Kagoshima university hospital
久留米大学病院(福岡県) Kurume university hosipital
東海大学病院(神奈川県) Tokai university hosipital


Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 19 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

2013 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 01 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

2013 Year 03 Month 19 Day

Last modified on

2019 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name