UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020229
Receipt number R000023356
Scientific Title Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Date of disclosure of the study information 2015/12/21
Last modified on 2015/12/24 16:29:05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma

Acronym

Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma

Scientific Title

Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma

Scientific Title:Acronym

Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma

Region

Japan


Condition

Condition

bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the change in asthma control obtained by switching from an ICS to a salmeterol/fluticasone combination (SFC) aerosol.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the PEF measured in the outpatient department and the ACT during 12 weeks

Key secondary outcomes

the information obtained from a questionnaire given to the patients and medication adherence.


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

The patients switched from their previous treatment with ICS to SFC, which contained the same amount of ICS. We evaluated the peak expiratory flow (PEF), ACT, and dose counter during a 12-week period.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The inclusion criteria were (i) patients who had been using ICS and LABA separately (ii) patients who had been using only ICS and who had an Asthma Control Test (ACT) score < 20.

Key exclusion criteria

severe infection, deep fungal infection, active infection, history of drug allergy to SFC, investigator judged as inappropriate for this study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kotaro Kajiwara

Organization

Matsuyama Red Cross Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

1 Bunkyocho, Matsuyama-shi, Ehime, Japan

TEL

+81899241111

Email

k-kajiwara@matsuyama.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kotaro Kajiwara

Organization

Matsuyama-Red-Cross-Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

1 Bunkyocho, Matsuyama-shi, Ehime, Japan

TEL

+81899241111

Homepage URL


Email

k-kajiwara@matsuyama.jrc.or.jp


Sponsor or person

Institute

Matsuyama-Red-Cross-Hospital

Institute

Department

Personal name



Funding Source

Organization

Matsuyama-Red-Cross-Hospital

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


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

2015 Year 12 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


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

2014 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 30 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

2015 Year 12 Month 16 Day

Last modified on

2015 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name