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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007543
Receipt No. R000008894
Scientific Title Study of the Effect of inhaled Short Acting Beta 2 Agonist(procaterol) on Breathlessness on Exertion in COPD patients.
Date of disclosure of the study information 2012/03/22
Last modified on 2012/03/21

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Basic information
Public title Study of the Effect of inhaled Short Acting Beta 2 Agonist(procaterol)
on Breathlessness on Exertion in COPD patients.
Acronym Study of procaterol on Breathlessness on exertion in COPD patients.
Scientific Title Study of the Effect of inhaled Short Acting Beta 2 Agonist(procaterol)
on Breathlessness on Exertion in COPD patients.
Scientific Title:Acronym Study of procaterol on Breathlessness on exertion in COPD patients.
Region
Japan

Condition
Condition COPD (Chronic Obstructive
Pulmonary Disease)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of inhaled short acting beta 2 agonist(procaterol) on breathlessness on exertion and effort of Activities of Daily Living(ADL) with COPD patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes severity of Breathlessness in exertions(Shortness of Breath Questionaire)
Key secondary outcomes Activities of Daily Living(ADL) using Actimarker

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 The usual adult dose is 20microg(2puffs)of procaterol hydrochloride hydrate. In the case of MEPTIN Kid Air use is 20microg(4puffs). The administration should be done about 15minutes before breathlessness on exertion is caused. The dosage may be adjusted according to the patient's age and severity of symptoms.
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 Patient will be eligible for inclusion in this study if all of the following criteria are met:
1.An outpatient with COPD, but do not change the state, during study.
2.A patient without experience of airway infection or exacerbation within 3 months.
3.Patients meet the COPD guidelines of the Japanese Respiratory Society. The GOLD stages are stage >= II
Key exclusion criteria A patient will not be eligible for inclusion in this study if any of the following criteria
1. There is a current diagnosis of asthma, in the opinion of the investigator
2. Patients with contraindication of procaterol inhalation.
3. The investigator judge to exclude
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Nagai
Organization Tokyo Women's Medical University
Division name First Department of Medicine
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiromasa Ogawa
Organization Tohoku University school of Medicine
Division name industrial medicine
Zip code
Address 2-1 Seiryo-cho, Aoba-ku, Sendai 980-8575, Japan
TEL 022-717-8006
Homepage URL
Email

Sponsor
Institute Tokyo Women's Medical University
Tohoku University Hospital
Wakayama Medical University
Tohoku Rosai Hospital

Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Tohoku University Hospital
Wakayama Medical University
Tohoku Rosai 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
Address
Tel
Email

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 和歌山県立医科大学(和歌山県)、東北大学大学病院(宮城県)、東北労災病院(宮城県)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 22 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 Preinitiation
Date of protocol fixation
2012 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 21 Day
Last modified on
2012 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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