UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001023
Receipt No. R000001233
Scientific Title Intervention trial of asthmatic cough therapy
Date of disclosure of the study information 2011/03/01
Last modified on 2012/02/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Intervention trial of asthmatic cough therapy
Acronym INTACT
Scientific Title Intervention trial of asthmatic cough therapy
Scientific Title:Acronym INTACT
Region
Japan

Condition
Condition cough variant asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of leukotriene receptor antagonist with that of inhaled corticosteroids on the onset of typical asthma and on the control of cough in patient with cough variant asthma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The onset of typical asthma for one year in patient with cough variant asthma.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 leukotriene receptor antagonist
Interventions/Control_2 inhaled corticosteroids
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
75 years-old >
Gender Male and Female
Key inclusion criteria The outpatient with cough variant asthma and whose symptom was controlled by initial treatment within three months.
Key exclusion criteria The patient with typical asthma.
The patient with atopic cough.
The patient with sinobronchial syndrome.
The patient with severe respiratory diseases.
The patient who is taking angiotensin-converting enzyme inhibitor.
The patient who has past history of serious adverse effect or allergy against leukotriene receptor antagonist or inhaled corticosteroids.
The case that the doctor judged the patient who dose not suit to the subject of the present study.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Fujimura
Organization Kanazawa University Graduate School of Medical Science, Japan
Division name Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address 13-1, Takara-machi, Kanazawa City, Ishikawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Fujimura
Organization Kanazawa University Graduate School of Medical Science, Japan
Division name Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address 13-1, Takara-machi, Kanazawa City, Ishikawa, Japan
TEL 076-265-2271
Homepage URL
Email fujimura@med3.m.kanazawa-u.ac.jp

Sponsor
Institute Japanese cough variant asthma research society
Institute
Department

Funding Source
Organization Japanese cough variant asthma research society
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 YES
Study ID_1 5391
Org. issuing International ID_1 Kanazawa University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 03 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 Completed
Date of protocol fixation
2007 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 02 Month 12 Day
Last modified on
2012 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.