UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011462
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kfunai@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.