UMIN-CTR Clinical Trial

Public title

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)

Acronym

Command Study
Clinical benefits of Aclidinium Bromide Compared with Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)

Scientific Title

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)

Scientific Title:Acronym

Command Study
Clinical benefits of Aclidinium Bromide Compared with Tiotropium in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease(COPD)

Region

Japan

Condition

Patients diagnosed with COPD in accordance to the GOLD guidelines

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tadashi Kamei

Organization

Kamei Internal Medicine and Respiratory Clinic

Division name

Medical director

Zip code

Address

3007-4, Otashimomachi, Takamatsu-shi, Kagawa

TEL

087-866-5001

Email

miyabin-kamei@mc.pikara.ne.jp

Name of contact person

1st name
Middle name
Last name	Nobuhide Mori

Organization

Mebix Inc.

Division name

Research Promotion Division

Zip code

Address

Akasaka InterCity. 1-11-44, Akasaka, Minato-ku, Tokyo

TEL

03-4362-4504

Homepage URL

Email

eklira@mebix.co.jp

Institute

Kamei Internal Medicine and Respiratory Clinic

Institute

Department

Personal name

Organization

KYORIN Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

09

Month

29

Day

Date of IRB

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

Other related information

Registered date

2015

Year

12

Month

01

Day

Last modified on

2016

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023112