UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009857
Receipt number R000011549
Scientific Title Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD
Date of disclosure of the study information 2013/01/24
Last modified on 2014/10/27 22:36:18

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Basic information

Public title

Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD

Acronym

Effects of a newly bronchodilator in patients with mild to moderate stable COPD

Scientific Title

Effects of a newly bronchodilator for lung hyperinflation and exercise tolerance in patients with mild to moderate stable COPD

Scientific Title:Acronym

Effects of a newly bronchodilator in patients with mild to moderate stable COPD

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy ofindacaterol and glycopyrronium bromide, this study is planned with lung hyperinflation and excercise tolerance in stable mild to moderate COPD patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Respiratory function

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Placebo-Placebo

Interventions/Control_2

Indacaterol-Placebo

Interventions/Control_3

Glycopyrronium bromide-Placebo

Interventions/Control_4

Indacaterol-Glycopyrronium bromide

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Clinical stable mild to moderate COPD patients with age more than 40 years
2. A post-bronchodilator forced expiratory volume in 1 second (FEV1) /forced vital capacity (FVC) of < 0.7. a post-bronchodilator forced expiratory volume <120% and >50% of the predicted normal value (i.e. stage Ior II)
3. Patients who provided written informed consent

Key exclusion criteria

1.other respiratory disease
2.severe other orgen disease
3.subjects who have been treated with LABA and/or LAMA in 2 weeks
4.subjects who have been shown exacervation.
5.subjects who doctors regarded unsuitable for this trial
6.subjects who had allergy for these drugs.

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kinoshita

Organization

Kurume University School of Medicine

Division name

Department of Medicine, Division of Respiratory, Neurology and Rheumatology

Zip code


Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takashi Kinoshita

Organization

Kurume University School of Medicine

Division name

Department of Medicine, Division of Respiratory, Neurology and Rheumatology

Zip code


Address


TEL

0942-35-3311

Homepage URL


Email



Sponsor or person

Institute

Kurume University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kurume University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

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

2013 Year 01 Month 24 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

2013 Year 01 Month 24 Day

Date of IRB


Anticipated trial start date

2013 Year 03 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

2013 Year 01 Month 24 Day

Last modified on

2014 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name