UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033398 |
|---|---|
| Receipt number | R000038074 |
| Scientific Title | An open-label, multi-institutional, randomized study to evaluate the additive effect of leukotriene receptor antagonist on cough score in patients with cough-variant asthma treated with inhaled corticosteroid |
| Date of disclosure of the study information | 2018/07/17 |
| Last modified on | 2018/07/16 10:46:43 |
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Basic information
Public title
An open-label, multi-institutional, randomized study to evaluate the additive effect of leukotriene receptor antagonist on cough score in patients with cough-variant asthma treated with inhaled corticosteroid
Acronym
Analysis of efficacy and safety of montelucast
Scientific Title
An open-label, multi-institutional, randomized study to evaluate the additive effect of leukotriene receptor antagonist on cough score in patients with cough-variant asthma treated with inhaled corticosteroid
Scientific Title:Acronym
Analysis of efficacy and safety of montelucast
Region
| Japan |
Condition
Condition
cough-variant asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to validate the additive efficacy of leukotriene receptor antagonist (LTRA) on cough score and respiratory function in patients with cough-variant asthma treated with inhaled corticosteroid (ICS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cough score and peak expiratory flow (PEF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
inhaled corticosteroids plus 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) age greater than 20; (2) dry cough continued for 3-weeks or more without wheezing; (3) cough responding to tulobuterol tapes; (4) normal respiratory function; (5) absence of rhinitis or sinusitis; (6) absence of symptom associated with gastroesophageal reflux disease; (7) not onset of respiratory infection within 3-weeks; and (8) no radiological findings
Key exclusion criteria
We excluded patients if they were diagnosed with bronchial asthma, atopic cough, sinobronchial syndrome, tuberculosis and lung cancer.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishimura |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
0783825660
nishiy@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Nagano |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunokicho, Chuo-ku, Kobe, Hyogo 650-0017, Japan
TEL
0783825660
Homepage URL
tnagano@med.kobe-u.a.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 17 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038074
