UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002668 |
|---|---|
| Receipt number | 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 11:14:57 |
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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
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
masaruh@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine, Department of Internal Medicine, Division of Respiratory Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003247
