UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011462 |
|---|---|
| Receipt number | R000013416 |
| Scientific Title | The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD. |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2014/09/12 17:57:14 |
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Basic information
Public title
The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.
Acronym
The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.
Scientific Title
The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.
Scientific Title:Acronym
The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer patients with COPD.
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the BUD/FM combination drug in additional administering group comparison to the standard treatment group for Lung cancer patient with COPD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation rate of 12 weeks after the operation. (The extension of hospitalization, the infectious disease or the additional dosage of the antibiotic and administering a systemic steroid and the decrease in the respiratory function; The sum total of each event that falls below the predictive value by 10% or more at the time of 12 of the week of after the operation is divided in the population).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tiotropium 18㎍ once daily for 13 weeks.
Interventions/Control_2
Tiotropium 18㎍ once daily with budesonide / formoterol combination drug 2 inhalation twice a day (morning and night time ) for 13 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age is full 20 or older-year patients at the time of agreement acquisition.
2) The patient of a perioperative period whom the examination doctor in charge diagnosed as lung cancer based on lung cancer handling agreement (the 7th edition)
3) The patient whom COPD diagnosis and a treatment guideline machine companion examination doctor in charge diagnosed as COPD
4) The patient who used tiotropium more than four week for COPD treatment.
5)Patients who agreed to participate in the study and signed informed consent form.
Key exclusion criteria
1)Patient that there is ICS/LABA mixing medicine in pre-administering within four weeks
2)Patient where exacerbation of COPD was admitted within four weeks
3)Patient that there is past of hypersensitivity in atropine, the kind edge material or tiotropium, budesonide or formoterol
4)Patient who has chronic ailments of lungs, heart, kidney, liver, and blood, etc.
5)Patient who has previous history of adrenal cortical insufficiency or accentuation syndrome
6)Patient who has glaucoma
7)Patient who has dysuria such as dysuria by enlarged prostate
8)Case who judged doctor in charge targets and it is improper
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University school of medicine
Division name
Surgery 1
Zip code
Address
1-20-1,Handayama,Higashi-ku, Hamamatsu-shi, Shizuoka-ken
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhito Funai |
Organization
Hamamatsu University School of Medicine
Division name
Surgery 1
Zip code
Address
1-20-1,Handayama,Higashi-ku, Hamamatsu-shi, Shizuoka-ken
TEL
053-435-2276
Homepage URL
kfunai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
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
| 2013 | Year | 08 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2014 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013416
