UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011773 |
|---|---|
| Receipt number | R000013047 |
| Scientific Title | The clinical efficacy of perioperative inhalation of budesonide/formoterol fumarate dehydrate for lung cancer patients with COPD. |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2022/05/06 22:31:02 |
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Basic information
Public title
The clinical efficacy of perioperative inhalation of budesonide/formoterol fumarate dehydrate for lung cancer patients with COPD.
Acronym
The clinical efficacy of perioperative inhalation of budesonide/formoterol fumarate dehydrate for lung cancer patients with COPD.
Scientific Title
The clinical efficacy of perioperative inhalation of budesonide/formoterol fumarate dehydrate for lung cancer patients with COPD.
Scientific Title:Acronym
The clinical efficacy of perioperative inhalation of budesonide/formoterol fumarate dehydrate for lung cancer patients with COPD.
Region
| Japan |
Condition
Condition
lung cancer patients with chronic obstructive pulmonary disease
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of perioperative administration of inhaled Tiotropium and Budesonide/Formoterol in lung cancer patients with COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lung function
Key secondary outcomes
QOL and CT or MRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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 inhalation once daily
Interventions/Control_2
Tiotropium once daily with budesonide / formoterol combination drug 2 inhalation twice a day
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
1) Lung cancer patients with COPD(FEV1/FVC<70% in stage I-III)
2) Patients who is scheduled for a standard surgery for lung cancer with clinical stage IA-IIB.
Key exclusion criteria
1) Patients with central lung cancer, wider atelectasis and tumor diameters more than 5cm
2) Patients with known history of asthma or chronic respiratory disease other than COPD, or a recent respiratory tract infection.
3) Patients receiving regular supplement oxygen or corticosteroid, or who had a significant concurrent disease other than COPD.
4) Case who judged doctor in charge targets and it is improper
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
TEL
043-222-7171
iyoshino@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Graduate School of Medicine
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
TEL
043-222-7171
Homepage URL
hidemisuzukidesu@yahoo.co.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
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
Chiba University Hospital Clinical Research C enter
Address
1-8-1, Inohana, Chiba, 260-8670, Japan
Tel
043-226-2616
prc-jim@chiba-u.jp
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 | 09 | Month | 17 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000013047
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000013047
Number of participants that the trial has enrolled
Results
No patient registration
Results date posted
| 2019 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No patient registration
Participant flow
No patient registration
Adverse events
No patient registration
Outcome measures
No patient registration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 17 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013047
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
