UMIN-CTR Clinical Trial

Public title

Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients.

Acronym

OPH-R-COPD-1402

Scientific Title

Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients.

Scientific Title:Acronym

OPH-R-COPD-1402

Region

Japan

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate improvement of daily physical activity accessed by uniaxial accelerometers (Kenz Lifecorder Ex) for outpatients with moderate to severe chronic obstructive pulmonary disease (COPD) treated with a long-acting muscarinic antagonist, glycopirronium, inhalation therapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Proportion of activity intensity of 1 or more, accessed by accelerometer.

Key secondary outcomes

1. Pulmonary functions; FVC, FEV1,FEV1%, V50, V25
2. QOL and activity ; CAT, SF-36, modified MRC
3. Physical activity; calorie consumption, steps, amount of exercise
4. Arterial blood test; PaO2, PaCO2
5. Exacerbation episode

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

glycopirronium inhalation therapy

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

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Age 40 years-old or older
2. A history of cigarette smoking or excessive exposure to smoke.
3. Clinically stable moderate-to-severe COPD, according to the Global Initiative on Obstructive Lung Disease (GOLD) staging.
4. Never treated with long-acting beta-agonists (LABA) or more than 4 weeks after last LABA inhalation.
5. Never treated with long-acting muscarinic antagonists (LAMA) or more than 4 weeks after last LAMA inhalation.
6. Able to walk independently or with a cane.
7. Sufficient cognitive function to follow the instructions for using the pulse oximetry equipment and accelerometers.
8. Written informed consent.

Key exclusion criteria

1. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
2. Closed angle glaucoma
3. Severe urination disorder
4. A history of hypersensitivity reaction against glycopirronium
5. A recent history of respiratory infection and acute exacerbation in the previous one month.
6. Clinically severe athma.
7. Other significant cardiac diseases or medical problems precluding ambulatory activity at hom
8. Physician's decision.

Target sample size

22

Name of lead principal investigator

1st name	Seigo
Middle name
Last name	Minami

Organization

Osaka Police Hospital

Division name

Department of Respiratory Medicine

Zip code

543-0035

Address

10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan

TEL

81-6-6771-6051

Email

seigominami@oph.gr.jp

Name of contact person

1st name	Seigo
Middle name
Last name	Minami

Organization

Osaka Police Hospital

Division name

Department of Respiratory Medicine

Zip code

543-0035

Address

10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan

TEL

81-6-6771-6051

Homepage URL

Email

seigominami@oph.gr.jp

Institute

Department of Respiratory Medicine, Osaka Police Hospital

Institute

Department

Personal name

Organization

Department of Respiratory Medicine, Osaka Police Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Comittee

Address

10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan

Tel

06-6771-6051

Email

shomu@oph.gr.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪警察病院（大阪）

Date of disclosure of the study information

2014

Year

06

Month

26

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

Enrolling by invitation

Date of protocol fixation

2014

Year

06

Month

26

Day

Date of IRB

Anticipated trial start date

2014

Year

06

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

06

Month

18

Day

Last modified on

2019

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016654