UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003781 |
|---|---|
| Receipt number | R000004572 |
| Scientific Title | The effect of pranlukast on alveolar exhaled nitric oxide in patients with asthma under inhaled corticosteroid therapy; Open-labeled, cross-over trial. |
| Date of disclosure of the study information | 2010/06/18 |
| Last modified on | 2013/02/09 15:43:01 |
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Basic information
Public title
The effect of pranlukast on alveolar exhaled nitric oxide in patients with asthma under inhaled corticosteroid therapy; Open-labeled, cross-over trial.
Acronym
Pranlukast and eNO in asthma under ICS therapy
Scientific Title
The effect of pranlukast on alveolar exhaled nitric oxide in patients with asthma under inhaled corticosteroid therapy; Open-labeled, cross-over trial.
Scientific Title:Acronym
Pranlukast and eNO in asthma under ICS therapy
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of present study is to analyze the effect of pranlukast to plumonary function test and alveolar exhaled nitric oxide in patients with asthma under inhaled corticosteroid therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exhaled nitric oxide (bronchial NO flux and alveolar NO concentration)
Plumonary function test (FEV1.0, V50, V25)
Key secondary outcomes
Peak Expiratory Flow Ratio
Asthma Control Test (ACT)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of oral pranlukast for 8 weeks
Interventions/Control_2
continuation of present therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All participants of this study must meet the following requirements
1. Patients on asthma treated with inhaled corticosteroid therapy over 2 months.
2. Patients with no administration of pranlukast or other leukotriene receptor antagonist over recent 4 weeks.
Key exclusion criteria
Exclusion criterias are as follows.
1. Patients during asthmatic attack,or infectious disease to treat with priority.
2. Patients with history of hypersensitivity to pranlukast.
3. Patients with complications as pneumothorax or severe heart failure.
4. Judgement of attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Chida |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal medicine
Zip code
Address
1-20-1, Handayama, Hamamatsu, Shizuoka, 433-8122, Japan
TEL
053-435-2263
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fujisawa |
Organization
Hamamatsu University School of Medicine, University Hospital
Division name
Department of Clinical Laboratory
Zip code
Address
TEL
Homepage URL
fujisawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
浜松医科大学付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22265857
Number of participants that the trial has enrolled
Results
The addition of oral pranlukast to ICS or ICS + LABA therapy may improve asthma control with reducing distal airway inflammation.
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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 18 | Day |
Last modified on
| 2013 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004572
