UMIN-CTR Clinical Trial

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

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Division of Respiratory Medicine, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name

Organization

Novartis Pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院、滋賀医科大学病院

Date of disclosure of the study information

2013

Year

10

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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