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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003781
Receipt No. 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

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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
Email

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
Email fujisawa@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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