UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019358 |
|---|---|
| Receipt number | R000022263 |
| Scientific Title | Perioperative effects of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in patients with untreated COPD requiring surgery for lung cancer |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2020/04/20 13:28:25 |
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Basic information
Public title
Perioperative effects of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in patients with untreated COPD requiring surgery for lung cancer
Acronym
Perioperative effects of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in untreated COPD patients with lung cancer
Scientific Title
Perioperative effects of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in patients with untreated COPD requiring surgery for lung cancer
Scientific Title:Acronym
Perioperative effects of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in untreated COPD patients with lung cancer
Region
| Japan |
Condition
Condition
COPD requiring surgery for lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the perioperative efficacy of inhaled long acting beta2 adrenergic agonist/long acting muscarinic antagonist in patients with untreated COPD requiring surgery for lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The comparison of lung function (FVC,FEV1.0) between before and after two weeks of medication. The comparison of FEV1.0 and predicted FEV1.0 after three months of surgery.
Key secondary outcomes
COPD assesement (CAT) score at the beginning of inhalation, after two weeks, and after three months of surgery. Pulmonary complications in the postoperative period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Inhaled long acting beta2 adrenegic agonist/long acting muscarinic antagonist daily from the preoperative period (approximately 2 weeks before the operation) to 3 months after the operation
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with newly diagnosed COPD during the cardio-pulmonary evaluation for lung surgery for lung cancer
Key exclusion criteria
Patients diagnosed with obstructive respiratory disorders other than COPD
Patients with prior treatment for COPD
Patients who cannot receive inhaled treatment because of its side-effect
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuyo |
| Middle name | |
| Last name | Tamiya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Respiratory medicine
Zip code
6028566
Address
465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
koma@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyo |
| Middle name | |
| Last name | Tamiya |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Respiratory medicine
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
Homepage URL
koma@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural Universityu of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Kyoto Prefectural University of Medicine
Address
Kajii-cho 465, Kamigyo-ku, Kyoto-city
Tel
075-251-5337
rinri@koto.kpu-m.ac.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
京都府立医科大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022263
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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