UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001007 |
|---|---|
| Receipt number | R000001213 |
| Scientific Title | The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug (2) Open-label, randomized, and cross-over study |
| Date of disclosure of the study information | 2008/02/04 |
| Last modified on | 2010/03/19 02:27:16 |
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Basic information
Public title
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
(2) Open-label, randomized, and cross-over study
Acronym
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
(2) Open-label, randomized, and cross-over study
Scientific Title
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
(2) Open-label, randomized, and cross-over study
Scientific Title:Acronym
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
(2) Open-label, randomized, and cross-over study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the inhibitory effects of a LT receptor antagonist, Pranlukast on peripheral airway inflammation in stable asthmatic patients who use FP/LABA combination drug regularly and are well-controlled or better based on self-evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Peripheral airway inflammation in induced sputum (Eosinophils, ECP and Eotaxin)
Key secondary outcomes
1.Asthmatic symptoms and QOL(AQLQ)
2.Pulmonary functions (PEF, FEV1, FEF50, FEF75)
3.Eosinophils in peripheral blood
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The first 4 weeks are treated with FP/LABA combination drug and Pranlukast.
The second 4 weeks are treated with only FP/LABA combination drug.
Interventions/Control_2
The first 4 weeks are treated with only FP/LABA combination drug.
The second 4 weeks are treated with. FP/LABA combination drug and Pranlukast.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with FP/LABA combination drug more than 3 months.
2.Stable asthmatic patients who evaluate themselves to be well-controlled or better.
Key exclusion criteria
1.Past treatments with anti-LT drugs in the previous 3 months.
2.Past treatments with oral corticosteroids in the previous 2 weeks.
3.Chronic obstructive lung disease(COPD) and other respitatory disease.
4.Severe liver, kidney, heart , hematic and other diseases
5.Inappropriate patients from the doctor's viewpoint.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Adachi |
Organization
Showa University School of Medicine
Division name
First Department of Internal Medicine
Zip code
Address
1-5-8, Hatanodai, Sinagawa-ku, Tokyo
TEL
03-3784-8000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
JA Tohno Kousei Hospital
Division name
Allergy and Respiratory Medicine
Zip code
Address
76-1, Toki-Cho, Mizunami City, Gifu Pref., 509-6101, Japan
TEL
0572-68-4111
Homepage URL
ohbayasi@nn.iij4u.or.jp
Sponsor or person
Institute
JA Tohno Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 02 | Month | 04 | 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
| 2007 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 01 | Day |
Last modified on
| 2010 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001213
