UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002665 |
|---|---|
| Receipt number | R000003245 |
| Scientific Title | Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics |
| Date of disclosure of the study information | 2009/10/25 |
| Last modified on | 2018/01/10 11:56:07 |
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Basic information
Public title
Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Acronym
Comparison of ciclesonide and fluticasone on small airway in asthmatics
Scientific Title
Comparative study of high-dose ciclesonide and fluticasone on small airway in asthmatics
Scientific Title:Acronym
Comparison of ciclesonide and fluticasone on small airway in asthmatics
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the efficacy and safety of high-dose and same-dose fluticasone propionate-dry powder inhalar and ciclesonide-hydrofluoroalkane on small airway funtion and inflammation in asthmatics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of lung function and respiratory resistance
Key secondary outcomes
Improvement of small airway inflammation and the frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A) ciclesonide (800mcg/, 14days)-28days washout-fluticasone (800mcg/, 14days)
Interventions/Control_2
B) fluticasone (800mcg/, 14days)-28days washout-ciclesonide (800mcg/, 14days)
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. Asthma is diagnosed in based on GINA 2006.
2. PC20 to methacholine < 16mg/mL.
3. non-smoker
4. stable status (>4wks)
Key exclusion criteria
1. Inhaled, oral and injective corticosteroids, leukotriene receptor antagonists, inhaled, oral and transdermal long acting beta2 agonists,sodiumchromoglicate, xanthine, immunosuppressive agents, and anti-allergic agents (include anti-IgE antibody) is used 4wks prior to screening.
2. Respiratory infections (within 4wks)
3. Other underlying diseases
4. Any psychological disease
5. Pregnacy
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisamichi Aizawa |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7560
kawayama_tomotaka@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomotaka Kawayama |
Organization
Kurume University School of Medicine
Division name
Department of Medicine, Division of Respirology, Neurology, and Rheumatology
Zip code
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7560
Homepage URL
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teijin phama corp.
Organization
Division
Category of Funding Organization
Profit organization
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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 25 | 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
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2009 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003245
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
