UMIN-CTR Clinical Trial

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
Email	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
Email	hidemisuzukidesu@yahoo.co.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013047