UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006652 |
|---|---|
| Receipt number | R000007865 |
| Scientific Title | Efficacy of inhaled tiotropium in patients with airflow limitation after pulmonary resection for lung cancer |
| Date of disclosure of the study information | 2011/11/02 |
| Last modified on | 2011/11/02 10:41:31 |
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Basic information
Public title
Efficacy of inhaled tiotropium in patients with airflow limitation after pulmonary resection for lung cancer
Acronym
Efficacy of tiotropium in patients with airflow limitation after lung cancer surgery
Scientific Title
Efficacy of inhaled tiotropium in patients with airflow limitation after pulmonary resection for lung cancer
Scientific Title:Acronym
Efficacy of tiotropium in patients with airflow limitation after lung cancer surgery
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tiotropium in patients with airflow limitation after lung cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative cardiopulmonary complications
Key secondary outcomes
Perioperative changes of white blood cell counts and C-reactive protein levels after surgery
Pulmonary functions after surgery
Lung cancer recurrence after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Tiotropium group
Interventions/Control_2
Control group
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Lung cancer patients with airflow limitation
Key exclusion criteria
Administration contraindication in inhaled tiotropium
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
National Hospital Organization Toneyama Hospital
Division name
General Thoracic Surgery
Zip code
Address
5-1-1 Toneyama, Toyonaka-City, Osaka
TEL
0668532001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
National Cerebral Cardiovascular Center Research Institute
Division name
Biochemistry
Zip code
Address
5-7-1 Fujishirodai, Suita-City, Osaka
TEL
06-6833-5012
Homepage URL
nojiri@ri.ncvc.go.jp
Sponsor or person
Institute
Department of General Thoracic Surgery, National Hospital Organization Toneyama Hospital
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
国立病院機構 刀根山病院
大阪大学医学部附属病院 呼吸器外科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 02 | 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
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 02 | Day |
Last modified on
| 2011 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007865
