UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023773
Receipt number 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 10:16:26

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

Value
https://center6.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