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

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 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


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

Value
https://center6.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