UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003618 |
|---|---|
| Receipt number | R000004387 |
| Scientific Title | Randamized clinical study with tioropium and formoterol/budezonide in COPD with asthma |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2010/05/15 12:32:57 |
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Basic information
Public title
Randamized clinical study with tioropium and formoterol/budezonide in COPD with asthma
Acronym
Randamized clinical study with tioropium and formoterol/budezonide in COPD with asthma
Scientific Title
Randamized clinical study with tioropium and formoterol/budezonide in COPD with asthma
Scientific Title:Acronym
Randamized clinical study with tioropium and formoterol/budezonide in COPD with asthma
Region
| Japan |
Condition
Condition
COPD with asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of comibination therapy with formoterolbudezonide and tiotropium for COPD with asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tiotropium + Formoterol/Budezonide
Interventions/Control_2
Tiotropium + Budezonide
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD with asthma who is in out-patient
Key exclusion criteria
# the patient who is not diagzoned as COPD
# the patient who needs other medicines
# the patient who has glaucoma or BPH
# the patient who has allergy in tiotropium, formoterol, budezonide
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshitaka Maeno |
Organization
Saitama Medical University
Division name
Pulmonary Division
Zip code
Address
38 Morohongo, Moroyama-machi, Iruma, Saitama, Japan
TEL
049-276-1319
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitaka Maeno |
Organization
Saitama Medical University
Division name
Pulmonary Division
Zip code
Address
TEL
049-276-1319
Homepage URL
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 15 | Day |
Last modified on
| 2010 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004387
