UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033824 |
|---|---|
| Receipt number | R000038473 |
| Scientific Title | Analysis of bilastine efficacy against chronic cough in patients with allergic rhinitis or atopic dermatitis. |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2018/08/20 18:14:35 |
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Basic information
Public title
Analysis of bilastine efficacy against chronic cough in patients with allergic rhinitis or atopic dermatitis.
Acronym
Analysis of bilastine efficacy against allergic cough.
Scientific Title
Analysis of bilastine efficacy against chronic cough in patients with allergic rhinitis or atopic dermatitis.
Scientific Title:Acronym
Analysis of bilastine efficacy against allergic cough.
Region
| Japan |
Condition
Condition
atopic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the efficacy of bilastine against chronic cough in patients with allergic rhinitis or atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japan-Leicester Cough Questionnaire
Key secondary outcomes
cough severity visual analogue scale and adverse effect.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hisatmine H1 receptor antagonist:bilastine
Interventions/Control_2
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)chronic non-productive cough
2)absence of wheeze and dyspnea
3)resistant to bronchodilator therapy
4)past history and/or complication of allergic rhinitis or atopic dermatitis
5)no medication that causes cough (ACE inhibitor, etc.)
6)over 20 years old
7)written consent form
Key exclusion criteria
1)abnormal findings of chest X-ray
2)patients judged inappropriate by physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 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
tnagano@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yasuda |
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
yyasuda@med.kobe-u.ac.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
神戸大学医学部附属病院（兵庫県）、明石医療センター（兵庫県）、加古川中央市民病院（兵庫県）、愛仁会 高槻病院（大阪府）、北播磨総合医療センター（兵庫県）、神戸医療センター（兵庫県）、なかじま内科クリニック（兵庫県）、中谷病院（兵庫県）、陰下内科（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038473
