UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012043
Receipt number R000014077
Scientific Title Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patients, using 3D CT Image analysis
Date of disclosure of the study information 2013/10/15
Last modified on 2016/04/16 17:32:50

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Basic information

Public title

Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patients, using 3D CT Image analysis

Acronym

Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patient

Scientific Title

Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patients, using 3D CT Image analysis

Scientific Title:Acronym

Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patient

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the magnitude of bronchodilation per lobe and or per generation of the bronchi after 4 to 5 weeks inhalation of beta 2 agonist followed by another 4 to 5 weeks inhalation of anti cholinergic agent, using 3D-CT airway imaging.
To examine the relationship between the magnitude of bronchodilation evaluated by 3D-CT and improved pulmonary function parameters.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To assess the change in airway inner area before and after inhalation of long-acting beta 2 agonist.

Key secondary outcomes

To assess the change in airway inner area before and after additional inhalation of anti-cholinergic agent.
To assess pulmonary function parameters in parallel and to examine the relationship of the change in airway inner area with that of pulmonary function parameters.


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

Inhalation of beta 2 agonist, indacaterol, 150ug Q.D. for 4 to 5 weeks, followed by additional inhalation of anti cholinergic agent, glycopyrronium 50ug Q.D. for another 4 to 5 weeks.

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Clinically stable patients with moderate to severe COPD,who are 60 years of age or older and have smoking history or current smokers and stop smoking at the time of giving the consent to this study..
They all provide written, informed consent.

Key exclusion criteria

Exclusion criteria: (1) Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. Asthma is excluded based on clinical history and/or laboratory findings, including levels of IgE and/or eosinophils in blood and/or sputum, but not based on reversibility of airflow limitation. (2) Those who can not adequately inhale beta 2 agonist and/or anti-cholinergic agent. (3) Those who have severe dysfunction in liver or kidney. (4) Those who have unstable cardiovascular disease or potentially fatal arrhythmia. (5) Those who have poor-controlled diabetes or hypertension. (6) Those who have glaucoma. (7) Those who have symptomatic prostate hypertrophy; however, they may be included if they are asymptomatic with pharmaco- therapy or post-surgery of TURP. (8) Those who are considered as inappropriate subjects for any reasons.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaharu Nishimura, Professor

Organization

Hokkaido University Graduate School of Medicine

Division name

Division of Respiratory Medicine

Zip code


Address

North 15, West 7, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5911

Email

ma-nishi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaoruko Shimizu, M.D.

Organization

Hokkaido University Hospital

Division name

First department of medicine

Zip code


Address

North 15, West 7, Kita-ku, Sapporo, Hokkaido

TEL

011-706-5911

Homepage URL


Email

okaoru@med.hokudai.ac.jp


Sponsor or person

Institute

Division of Respiratory Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Novartis Pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Division of Respiratory Medicine, Department of Internal Medicine, Shiga University of Medical Science,

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

北海道大学病院、滋賀医科大学病院


Other administrative information

Date of disclosure of the study information

2013 Year 10 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

Completed

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2015 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 15 Day

Last modified on

2016 Year 04 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014077


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name