UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000983
Receipt number R000001155
Scientific Title Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.
Date of disclosure of the study information 2008/01/13
Last modified on 2010/02/19 22:06:35

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Basic information

Public title

Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.

Acronym

Study to compare the effect of HFA-BDP and FP-DPI in bronchial asthma.

Scientific Title

Open-label, single-center, randamized and parallel-group study to compare the effect of hydrofluoroalkane-134a beclomethasone dipropionate (HFA-BDP) and that of fluticasone propionate dry powder inhaler (FP-DPI) on large and small airways involvement in bronchial asthma.

Scientific Title:Acronym

Study to compare the effect of HFA-BDP and FP-DPI 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 fluticasone propionate dry powder inhaler on large and small airways involvement in bronchial asthma using impulse oscillometry, chest computed tomography, continuous methacholine inhalation method, health related quality of life questionnaires, etc.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Parameters of impulse oscillometry at 0, 4, 8 and 12 weeks.
Indices of chest computed tomography at 0 and 12 weeks.
Indices of continuous methacholine inhalation method at 0 and 12 weeks.

Key secondary outcomes

1 Values of pulmonary function at 0, 4, 8 and 12 weeks.
2 Inflammatory biomarkers of induced sputum at 0 and 12 weeks.
3 Exhaled nitric oxide concentration at 0 and 12 weeks.
4 Scores of questionnaires at 0 and 12 weeks.
5 Wheezing on auscultation at 0, 4, 8 and 12 weeks.


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 bid
12 weeks

Interventions/Control_2

Fluticasone propionate dry powder inhaler 200 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 smokers
2 Past treatment with inhaled corticosteroids ever
3 Past treatment with oral corticosteroids in the previous 2 months
4 Intractable infection such as systemic fungal infection
5 Allergy to the drugs used in this study
6 Tuberculosis or other respiratory infection
7 Obstructive lung disease such as COPD or bronchiectasis
8 Adrenal insufficiency
9 Dependency on systemic steroids
10 Glaucoma or cataract
11 Pregnancy or lactation
12 Inappropriate patients from the doctor's viewpoint

Target sample size

60


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, Japan.

TEL

075-751-3830

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tomoshi Takeda

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

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

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

2008 Year 01 Month 13 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

2007 Year 01 Month 09 Day

Date of IRB


Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

2009 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 01 Month 13 Day

Last modified on

2010 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name