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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002668
Receipt No. R000003247
Scientific Title Evaluation of bronchodilation induced by beta-adrenergic agents in COPD patients. -Three-dimensional CT Image analysis-
Date of disclosure of the study information 2009/10/26
Last modified on 2012/10/27

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Basic information
Public title Evaluation of bronchodilation induced by beta-adrenergic agents in COPD patients.
-Three-dimensional CT Image analysis-


Acronym Evaluation of bronchodilation induced by beta-adrenergic agents in COPD patients.
Scientific Title Evaluation of bronchodilation induced by beta-adrenergic agents in COPD patients.
-Three-dimensional CT Image analysis-


Scientific Title:Acronym Evaluation of bronchodilation induced by beta-adrenergic agents in COPD patients.
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyzethe magnitude of bronchodilation at various sites throughout the lung of patients with COPD in response to daily inhalations of Salmeterol/Fluticasone, using 3D-CT airway imagings.
To investigate the relationship between the magnitude of bronchodilation evaluated by 3D-CT imagings and improved pulmonary function parameters and explore the relationship at each generation of bronchi and/or at each lobe.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between change in airway caliber and pulmonary function parameter induced by inhaled Salmeterol/Fluticasone.
Key secondary outcomes Pulmonary function parameters
Airway inner luminal area
Airway wall area percent

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Salmeterol/Fluticasone
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Clinically stable COPD patients with age more than 50 years
Key exclusion criteria Patients with signs of any other major pulmonary diseases such as bronchial asthma, pulmonary fibrosis, and pulmonary cancer according to chest radiographs, CT and other laboratory findings.

Patients judged to be inappropriate by respirologists
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Nishimura
Organization Hokkaido University Graduate School of Medicine
Division name Department of Internal Medicine, Division of Respritory Medicine
Zip code
Address Kita 15 Nishi 7 kita-ku Sapporo Hokkaido
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Hasegawa
Organization Hokkaido University Hospital, First Department of Medicine
Division name Department of Internal Medicine, Division of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email masaruh@med.hokudai.ac.jp

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

Funding Source
Organization Astra Zeneca
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 10 Month 26 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
2009 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 26 Day
Last modified on
2012 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003247

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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