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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012043
Receipt No. 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

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

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
URL(English) https://upload.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


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