UMIN-CTR Clinical Trial

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
Email	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
Email	koma@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural Universityu of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022263