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
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
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
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
