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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023773
Receipt No. R000027386
Scientific Title Efficacy of long-acting muscarinic antagonist for chronic cough
Date of disclosure of the study information 2016/09/20
Last modified on 2018/08/24

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Basic information
Public title Efficacy of long-acting muscarinic antagonist for chronic cough
Acronym LAMA for chronic cough
Scientific Title Efficacy of long-acting muscarinic antagonist for chronic cough
Scientific Title:Acronym LAMA for chronic cough
Region
Japan

Condition
Condition chronic cough
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of LAMA for chronic cough
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective symptoms
Key secondary outcomes Pulmonary function and so on

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 tiotropium bromide
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Patients with cough despite treatment of inhaled corticosteroids and long-actin adrenergic bronchodilator
Key exclusion criteria Patietns with closed-angle glaucoma or benign prostatic hypertrophy and patients who are thoght to be inappropriate by research physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisako Matsumoto
Organization Graduate School of Medicine, Kyoto University
Division name Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL +81-75-751-3830
Email hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadao Nagasaki
Organization Graduate School of Medicien, Kyoto University
Division name Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL +81-75-751-3830
Homepage URL
Email nagasaki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Scholarship
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 C1195
Org. issuing International ID_1 Ethics Committee of Kyoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 20 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
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 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
2016 Year 08 Month 26 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027386

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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