UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of bronchodilation induced by beta-adrenergic agent and anti-cholinergic agent in COPD patients, using 3D CT Image analysis
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masaharu Nishimura, Professor
Organization	Hokkaido University Graduate School of Medicine
Division name	Division of Respiratory Medicine
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	Kaoruko Shimizu, M.D.
Organization	Hokkaido University Hospital
Division name	First department of medicine
Address	North 15, West 7, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5911
Homepage URL
Email	okaoru@med.hokudai.ac.jp

Sponsor
Institute	Division of Respiratory Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014077