UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016184 |
|---|---|
| Receipt number | R000018739 |
| Scientific Title | Clinical trial on Efficacy and Safey of dual bronchodilator (glycopyronium and indacaterol) in perioperative management of chest surgery |
| Date of disclosure of the study information | 2015/01/12 |
| Last modified on | 2019/02/04 14:50:03 |
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Basic information
Public title
Clinical trial on Efficacy and Safey of dual bronchodilator (glycopyronium and indacaterol) in perioperative management of chest surgery
Acronym
Phase II study of glycopyronium and indacaterol in chest surgery
Scientific Title
Clinical trial on Efficacy and Safey of dual bronchodilator (glycopyronium and indacaterol) in perioperative management of chest surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takanori AYABE |
Organization
University of Miyazaki
Faculty of Medicine
Division name
Department of Surgery II
Zip code
Address
5200, Kihara, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL
0985-85-2291
tayabe@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori AYABE |
Organization
University of Miyazaki, Faculty of Medicine
Division name
Depatment of Surgery II
Zip code
Address
5200, Kihawa, Kiyotake, Miyazaki, Miyazaki, 889-1692, JAPAN
TEL
0985-85-2291
Homepage URL
tayabe@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Department of Surgery II
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018739
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| Registered date | File name |
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| Registered date | File name |
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