UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014303 |
|---|---|
| Receipt number | R000016654 |
| Scientific Title | Effects of glycopirronium inhalation therapy evaluated by change of physical activity for untreated chronic obstructive pulmonary disease (COPD) patients. |
| Date of disclosure of the study information | 2014/06/26 |
| Last modified on | 2019/06/22 12:28:05 |
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Basic information
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
Condition
Chronic Obstructive Pulmonary Disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
seigominami@oph.gr.jp
Public contact
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
seigominami@oph.gr.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Osaka Police Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Comittee
Address
10-31 Kitayama-cho Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
Tel
06-6771-6051
shomu@oph.gr.jp
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
大阪警察病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 26 | 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
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
Other related information
Management 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
