UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002800 |
|---|---|
| Receipt number | R000003392 |
| Scientific Title | Efficasy of assist usage of inhaled procaterol on improving dyspnea symptom and QOL in daily activities of patients with COPD |
| Date of disclosure of the study information | 2009/11/25 |
| Last modified on | 2010/06/16 00:16:41 |
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Basic information
Public title
Efficasy of assist usage of inhaled procaterol on improving dyspnea symptom and QOL in daily activities of patients with COPD
Acronym
Efficasy of assist usage of inhaled procaterol in COPD treatment
Scientific Title
Efficasy of assist usage of inhaled procaterol on improving dyspnea symptom and QOL in daily activities of patients with COPD
Scientific Title:Acronym
Efficasy of assist usage of inhaled procaterol in COPD treatment
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improved effects of assist use of inhaled procaterol on dyspnea symptoms and QOLs of Patients with COPD
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of procaterol on improving bronchoconstriction of distal airways
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
dyspnea symptom score
QOLs
Key secondary outcomes
pulmonary function tests
impulse oscillometry system (IOS)
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
Inhaled procaterol
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were outpatients with COPD in the 2nd (moderate) to 4th COPD stage (very severe) , who stably used inhaled tiotropium bromide for more than 6 months.
Key exclusion criteria
1) present smokers and ex-smokers within 1 year, 2) treatment with other SABAs in the previous 3 months, 3) treatment with oral or intravenous corticosteroids in the previous 3 months, 4) new induction of home oxygen therapy (HOT) in the previous 6 months, 5) other chronic respiratory disease, 6) taking medication for chronic respiratory infectious diseases, 7) severe hepatic, heart or renal disease, hematologic diseases or other grave complications, 8) history of poor drug compliance, and 9) inappropriate from the doctor's perspective.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno-Kousei Hospital
Division name
Dept. of Allergy and Respiratory Medicine
Zip code
Address
76-1,Toki-Cjo, Mizunami City, Gifu, 509-6101, Japan
TEL
+81-572-68-4111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno-Kousei Hospital
Division name
Dept. of Allergy and Respiratory Medicine
Zip code
Address
76-1,Toki-Cjo, Mizunami City, Gifu, 509-6101, Japan
TEL
+81-572-68-4111
Homepage URL
http://www.tohno.gfkosei.or.jp/
ohbayasi@nn.iij4u.or.jp
Sponsor or person
Institute
Dept. of Allergy and Respiratory Medicine, Tohno-Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
Dept. of Allergy and Respiratory Medicine, Tohno-Kousei Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
東濃厚生病院アレルギー呼吸器科 外来
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 25 | Day |
Last modified on
| 2010 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003392
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
