UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001083 |
|---|---|
| Receipt number | R000001303 |
| Scientific Title | Open-label, single-center, randomized and parallel-group study to exmamine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide. |
| Date of disclosure of the study information | 2008/03/18 |
| Last modified on | 2013/04/14 21:22:55 |
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Basic information
Public title
Open-label, single-center, randomized and parallel-group study to exmamine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.
Acronym
Study to examine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.
Scientific Title
Open-label, single-center, randomized and parallel-group study to exmamine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.
Scientific Title:Acronym
Study to examine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of montelukast sodium and ciclesonide on peripheral airway inflammation and airway function in asthma using alveolar nitric oxide and impulse oscillometry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Fractional exhaled nitric oxide levels at 0, 4, 12 and 24 weeks.
Values of impulse oscillometry at 0, 4, 12 and 24 weeks.
Key secondary outcomes
Pulmonary function levels at 0, 4, 12 and 24 weeks.
Scores of questionnaires at 0, 4, 12 and 24 weeks.
Levels of inflammatory biomarkers in induced sputum at 0 and 24 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
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Add montelukast sodium 10mg (p.o) once daily to the current medication for 24 weeks
Interventions/Control_2
Add inhaled ciclesonide 400mcg once daily
to the current medication for 24 weeks
Interventions/Control_3
Continue the current medication for 24 weeks
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
1 Never smoker or ex-smoker(< 5 pack-year)
2 Stable for more than 3 months under the treatment with inhaled corticosteroids.
3 No current usage of anti-leukotriene agents
4 Presenting high levels of alveolar NO
Key exclusion criteria
1 Exacerbations of asthma within 1 months
2 Sensitized to the drugs used in this study
3 Pregnancy or lactation
4 Those who are considered inappropriate by physicians in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisako Matsumoto |
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisako Matsumoto |
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
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
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 | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | 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
| 2008 | Year | 03 | Month | 18 | Day |
Last modified on
| 2013 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001303
| 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 |
