UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of long-acting muscarinic antagonist for chronic cough
Title of the study (Brief title)	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	Hisako Matsumoto
Organization	Graduate School of Medicine, Kyoto University
Division name	Respiratory Medicine
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	Tadao Nagasaki
Organization	Graduate School of Medicien, Kyoto University
Division name	Respiratory Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027386