UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial on Efficacy and Safey of dual bronchodilator (glycopyronium and indacaterol) in perioperative management of chest surgery
Title of the study (Brief title)	Phase II study of glycopyronium and indacaterol in chest surgery
Region	Japan

Condition
Condition	Lung cancer, thoracic malignant diseases (metastatic tumors due to breast cancer, colon cancer, and other malignancies), and benign pulmonary tumors
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	As a perioperative management in chest surgery, to elucidate an efficacy on improvement of pulmonary function by intervention of dual bronchodilator (glycopyrronium and indacaterol).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1)Pre- and postoperative pulmonary function test (FVC, FEV1, inspiratory capacity, flow volume curve) 2)Changed rates of actual FEV1 value (pre- and postoperative values),(COPD-group and non-obstructive groups with and without intervention of bronchodilators) 3)Improvement of the residual lung volume by analysis of computed tomographic volumetry (changed and expanded rates) 4)Changes of QOL 5)'Lung age'
Key secondary outcomes	1)Changes of QOL 2)Safety, adverse event(NCI-CTCAE, ver 4.0) 3)Postoperative complications 4)Analysis of free-radical productives (oxidative stress and anti-oxidative capacity) 5)Changes of postoperative intrapleural pressure 6)Changes based on the resected location (Lt. vs Rt., Upper lobe vs middle lobe vs lower lobe)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1)Non-obstructive airflow group (normal pulmonary function group). One is group of glycopyrronium and indacaterol (LAMA/LABA) without glaucoma, prostatomegaly, and dysuria, after randamization of the above group, which are divided in two groups of control and LAMA/LABA groups. The other group of indacaterol (LABA) with glaucoma, prostatomegaly, and dysuria. Intervention of bronchodilator is between preoperative 1 week and postoperative 4 weeks.
Interventions/Control_2	2)Obstructive airflow group (COPD group, %FEV1<70%, GOLD-I, II, III). One is group of glycopyrronium and indacaterol (LAMA/LABA) without glaucoma, prostatomegaly, and dysuria. The other group of indacaterol (LABA) with glaucoma, prostatomegaly, and dysuria. Intervention of bronchodilator is between preoperative 1 week and postoperative 4 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)wedge resection, lobectomy, peumonectomy, with video-assisted thoracic surgery and/or open thoracotomy 2)pulmonary emphysematous disease, COPD, untreated patient with flow-obstructive disease 3)no smoking patients (past smoker, current smoker, non-smoker) 4)toleratable patient for lung resection with normal or decreased lung function 5)interstitial pneumonia 6)emphysematous changes in lung field by CT-images 7)no complication of viable double cancers 8)Performance status 0-2 (Eastern Cooperative Oncology Group) 9)organ function before 2 weeks. WBC>=4,000/mm3, Hemoglobin>=9.0g/dl, Platelet>=100,000/mm3, AST<=100IU/L, ALT<=100IU/L, Total-bil<=1.5 mg/dl, Serum creatinin<=1.5mg/dl (Ccr>=45ml/min), Urine protein<=1+, arterial blood gas >=60 Torr(or > =SPO2 90% 10)Informed consent(document) 11)expected survival >= 3 months 12)Informed consent for clinical trial (document) 13)based on the preoperative examination and on the above criteria from 1) to 12), available and bearable for general anesthesia, video-assisted thoracic surgery or open thoracotomy, and lobectomy.
Key exclusion criteria	1)closed angle glaucoma 2)prostatomegaly and dysuria 3)past medical history of hypersensitivity, allergy 4)bronchodilator treatment except for LAMA/LABA and LABA 5)under treatment of Bronchial asthma 6)severe hypokalemia 7)atrial fibrillation 8)Others. Patients judged for inappropriation by attending physician or lead principal investigator
Target sample size	160

Research contact person
Name of lead principal investigator	Takanori AYABE
Organization	University of Miyazaki Faculty of Medicine
Division name	Department of Surgery II
Address	5200, Kihara, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL	0985-85-2291
Email	tayabe@med.miyazaki-u.ac.jp

Public contact
Name of contact person	Takanori AYABE
Organization	University of Miyazaki, Faculty of Medicine
Division name	Depatment of Surgery II
Address	5200, Kihawa, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL	0985-85-2291
Homepage URL
Email	tayabe@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital Department of Surgery II
Institute
Department

Funding Source
Organization	University of Miyazaki Hospital Department of Surgery II
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 01 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 08 Month 10 Day
Date of closure to data entry	2017 Year 08 Month 10 Day
Date trial data considered complete	2017 Year 08 Month 10 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 12 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018739