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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001006
Receipt No. R000001212
Scientific Title The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug –(1) Open-label, randomized and comparative study–
Date of disclosure of the study information 2008/02/04
Last modified on 2010/03/19

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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
–(1) Open-label, randomized and comparative study–
Acronym The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
–(1) Open-label, randomized and comparative study–
Scientific Title The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
–(1) Open-label, randomized and comparative study–
Scientific Title:Acronym The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug
–(1) Open-label, randomized and comparative 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 and ECP)
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 Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatments with FP/LABA combination drug and Pranlukast for 4 weeks.
Interventions/Control_2 Treatments with FP/LABA combination drug for 4 weeks.
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
Email

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
Email ohbayasi@nn.iij4u.or.jp

Sponsor
Institute JA Tohno Kousei Hospital
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001212

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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