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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013831
Receipt No. 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

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

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
URL(English) https://upload.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


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