UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical benefits of twice daily medication of Aclidinium Bromide Compared with once daily medication of Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Title of the study (Brief title)	Command Study Clinical benefits of Aclidinium Bromide Compared with Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)
Region	Japan

Condition
Condition	Patients diagnosed with COPD in accordance to the GOLD guidelines
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacies of twice daily administration of aclidinium bromide (hereinafter referred to as aclidinium) and once daily administration of tiotropium bromide (hereinafter referred to as tiotropium) on respiratory function, COPD symptoms, QOL, and physical activity in patients with moderate to severe COPD as a pilot study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	FEV1AUC
Key secondary outcomes	-Index of respiratory function test(FVC, FEV1, %FEV1, FEV1%, VC, IC) -FeN0 -Questionnaires (SGRQ, mMRC questionnaire, SOBQ, SF-8) -Activity level -Laboratory test (hsCRP value, number of eosinophils, number of neutrophils, WBC) -Frequency of COPD exacerbation -Correlation between questionnaires and FEV1AUC -Summary scores and subscales of SF-8 -Correlation between Activity level and COPD index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aclidinium bromide Genuair inhaler 400 microgram as Aclidinium bromide is inhaled twice daily, in the morning (9:00-11:00) and at night (21:00-23:00) for 8 weeks
Interventions/Control_2	Tiotropium bromide HandiHaler inhaler One capsule (18 microgram as tiotropium) is administered once daily, at night (20:00-22:00) for 8 weeks. Respimat inhaler Two inhalations (5 microgram as tiotropium) are administered once daily, at night (20:00-22:00) for 8 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet all the conditions below at Visit 1 will be eligible as subjects. (1)Having provided written consent (2)Age more than 40 years (3)Having COPD with severity 2-3 (moderate to severe), as classified according to the GOLD guidelines (4)Having FEV1/FVC value of <70% after bronchodilator inhalation, within the past year (5)Having FEV1 >= 30% and < 80% of the predicted value (6)Being well controlled by COPD medications except long-acting anticholinergic agents for more than 4 weeks (7)Having smoking history >= 10 pack-years
Key exclusion criteria	Patients who meet any of the conditions below at Visit 1 will not be eligible as subjects. (1)History and concurrent medical conditions -Having bronchial asthma -Having pulmonary fibrosis definitely diagnosed by CT or HRCT (high-resolution CT) -Having respiratory tract infection (including upper-airway inflammation) within the past 4 weeks -Having hospitalization due to acute exacerbation of COPD within the past 3 months -Having serious complications such as respiratory, cardiac, hepatic, renal, pulmonary, or hematologic disease or others that would interfere with participation in the study -Having malignant tumor or a history of malignant tumor within the past 5 years -Having contraindication of anticholinergic agents (2)Medications and therapies -Either or both of ICS and ICS/LABA agents has been switched or planned to be switched within the 4 weeks prior to patient enrollment during the run-in/treatment periods or planned to be switched Use of anticholinergic agents (inhaled, oral, etc.) -LABA has been switched or planned to be switched during the run-in period -Use of cholinesterase inhibitors -Use of systemic steroids* -Use of theophylline products* except for sustained-release oral theophylline products *Except for the treatment of COPD exacerbation -Patients under oxygen therapy for more than 15 hours a day -Patients whoes pulmonary rehabilitation program has been changed within the past 6 weeks -Patients under acute-phase pulmonary rehabilitation program -Patients under non-invasive ventilation -Patients having a history of side effects anticholinergic agents (3)Others -Patients who cannot use inhaler correctly -Patients who cannot perform a respiratory function test properly -Patients who hope to change their smoking habit -Women who are pregnant, lactating, or hoping to become pregnant during the study period -Patients who have been judged ineligible for the study by the investigator or sub-investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Tadashi Kamei
Organization	Kamei Internal Medicine and Respiratory Clinic
Division name	Medical director
Address	3007-4, Otashimomachi, Takamatsu-shi, Kagawa
TEL	087-866-5001
Email	miyabin-kamei@mc.pikara.ne.jp

Public contact
Name of contact person	Nobuhide Mori
Organization	Mebix Inc.
Division name	Research Promotion Division
Address	Akasaka InterCity. 1-11-44, Akasaka, Minato-ku, Tokyo
TEL	03-4362-4504
Homepage URL
Email	eklira@mebix.co.jp

Sponsor
Institute	Kamei Internal Medicine and Respiratory Clinic
Institute
Department

Funding Source
Organization	KYORIN Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 29 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 12 Month 01 Day
Last modified on	2016 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023112