UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000632
Receipt number R000000766
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.
Date of disclosure of the study information 2007/03/09
Last modified on 2007/03/09 15:34:21

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Basic information

Public title

Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.

Acronym

Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.

Scientific Title

Open-label, single-center, randomized and parallel-group study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma assessed using impulse oscillometry system.

Scientific Title:Acronym

Controlled study to compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and Chlorofluorocarbon beclomethasone dipropionate in bronchial asthma.

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the effect of Hydrofluoroalkane-134a beclomethasone dipropionate and that of Chlorofluorocarbon beclomethasone dipropionate on small airways involvement in asthma with a use of impulse oscillometry system.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Parameters of impulse oscillometry system.

Key secondary outcomes

1 Symptoms
2 Wheezing on auscultation
3 Methacholine airway responsiveness
4 Pulmonary function
5 Lung volume measurement
6 Inflammatory biomarkers of induced sputum and peripheral blood
7 Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hydrofluoroalkane-134a beclomethasone dipropionate 200 mcg bids
12 weeks

Interventions/Control_2

Chlorofluorocarbon dipropionate 400 mcg bid
12 weeks

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inhaled corticosteroids-naive mild-to-moderate asthmatic patients

Key exclusion criteria

1 Current smoker
2 Past treatment with inhaled corticosteroids
3 Receiving oral corticosteroids in the previous 2 months

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Niimi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3830

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masafumi Yamaguchi

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3830

Homepage URL


Email



Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2007 Year 03 Month 09 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

2005 Year 04 Month 13 Day

Date of IRB


Anticipated trial start date

2005 Year 05 Month 01 Day

Last follow-up date

2006 Year 07 Month 01 Day

Date of closure to data entry

2006 Year 07 Month 01 Day

Date trial data considered complete

2006 Year 07 Month 01 Day

Date analysis concluded

2006 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 03 Month 09 Day

Last modified on

2007 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000766


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name