UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001023 |
|---|---|
| Receipt number | 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 10:48:12 |
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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
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
fujimura@med3.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Japanese cough variant asthma research society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001233
