UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001288 |
|---|---|
| Receipt number | R000001570 |
| Scientific Title | Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids : A open-label multicenter study |
| Date of disclosure of the study information | 2008/10/01 |
| Last modified on | 2008/08/02 17:03:23 |
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Basic information
Public title
Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids : A open-label multicenter study
Acronym
Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids
Scientific Title
Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids : A open-label multicenter study
Scientific Title:Acronym
Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate add-on effect of Montelukast therapy for respiratory function and airway inflammation for unstable asthma symptom despite with inhaled corticosteroids therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exhaled breath condensate(IL-4, RANTES, IL-8, TNF-a, IP-10, TGF-b, H2O2, sICAM1, Leukotrienes, etc.)
Respiratory function (peak expiratory flow)
Key secondary outcomes
Asthma Control Test
Asthma Quality of Life Questionnaire
clinical and laboratory adverse experiences
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment for 8 weeks with montelukast 10 mg once daily
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
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Patients had the consent for the study
2) Patients have mild-to-moderate persistent asthma according to Japanese asthma guidelines in 2006
3) under 24 score of Asthma Control Test
4) Patients had used inhaled corticosteroids over 8 weeks.
Key exclusion criteria
1) Patients with a history of hypersensitivity to montelukast
2) Patients on continuous therapy with oral corticosteroids
3) In-patients for asthma within one month prior to entry the study
4) Patients with complications that could affect the evaluation of efficacy, such as bronchiectasis.
5) Pregnant women and women suspected of being pregnant, breast-feeding women
6) Patients who physician judged "not eligible"
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Kawase |
Organization
Osaka university Graduate school of medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2 Yamadaoka, Suita city, Osaka, 565-0871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Yoshida |
Organization
Osaka university Graduate school of medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
TEL
06-6879-3831
Homepage URL
hiroyoshida@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2008 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001570
| 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 |
