UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013831
Receipt number R000016140
Scientific Title Effect of inhaled corticosteroid therapy in pulmonary sarcoidosis patients who manifest airflow limitation
Date of disclosure of the study information 2014/04/30
Last modified on 2015/05/30 22:38:17

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Basic information

Public title

Effect of inhaled corticosteroid therapy in pulmonary sarcoidosis patients who manifest airflow limitation

Acronym

Effect of inhaled corticosteroid therapy on pulmonary sarcoidosis

Scientific Title

Effect of inhaled corticosteroid therapy in pulmonary sarcoidosis patients who manifest airflow limitation

Scientific Title:Acronym

Effect of inhaled corticosteroid therapy on pulmonary sarcoidosis

Region

Japan


Condition

Condition

Pulmonary sarcoidosis patients who revealed airflow limitation in peak flow tests, increased respiratory resistance in IOS, or increased WA% in HRCT.

Classification by specialty

Medicine in general Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence of inhaled ciclesonide (400 maicrogram, twice daily, for three months) on pulmonary function tests, impulse oscillometry system (IOS) and HRCT of pulmonary sarcoidosis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the influence of inhaled ciclesonide (400maicrogram, twice daily, for three months) on pulmonary function tests, impulse oscillometry system (IOS) and HRCT of pulmonary sarcoidosis patients.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

inhaled ciclesonide (400maicrogram, twice daily, for three months)

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1. patients with the definite diagnosis established when the clinicoradiologic findings were supported by the histologic evidence of noncaseating epitheloid cell granulomas and exclusion of other diseases capable of producing similar histologic or clinical features.
2. patients whose FEV1/FVC is under 80%, whose R5-R20 score is over 0.03, or whose WA% is over 55%.
3. patients over 20 years old who can give the documents which agree in participating this study

Key exclusion criteria

1. patients with heart failure
2. patients with renal failure
3. patients with past hisotry of bronchial asthma
4. ex, or current smokers
5. patients with pulmonary disease except for pulmonary sarcoidosis
6. patients whose participations in this study are thought to be inappropriate.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Suzuki

Organization

Graduate School of Medicine, Chiba University, Chiba, Japan

Division name

Department of Respirology

Zip code


Address

1-8-1 Inohana Chuo-ku, Chiba 260-8670, Japan

TEL

043-226-2800

Email

toshiosuzuki@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Suzuki

Organization

Graduate School of Medicine, Chiba University, Chiba, Japan

Division name

Department of Respirology

Zip code


Address

1-8-1 Inohana Chuo-ku, Chiba 260-8670, Japan

TEL

043-226-2800

Homepage URL


Email

toshiosuzuki@chiba-u.jp


Sponsor or person

Institute

Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan

Institute

Department

Personal name



Funding Source

Organization

self funding

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

千葉大学医学部附属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 30 Day


Related information

URL releasing protocol


Publication of results

Partially 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

Open public recruiting

Date of protocol fixation

2014 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 04 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

2014 Year 04 Month 28 Day

Last modified on

2015 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name