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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001833
Receipt No. R000002191
Scientific Title The efficacy of the assist use of short-acting beta2 stimulant procaterol on the daily activity in COPD patients. NIIGATA Multicenter Study
Date of disclosure of the study information 2009/03/31
Last modified on 2011/09/30

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Basic information
Public title The efficacy of the assist use of short-acting beta2 stimulant procaterol on the daily activity in COPD patients. NIIGATA Multicenter Study
Acronym NIIGATA ASSIST STUDY
Scientific Title The efficacy of the assist use of short-acting beta2 stimulant procaterol on the daily activity in COPD patients. NIIGATA Multicenter Study
Scientific Title:Acronym NIIGATA ASSIST STUDY
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of the assist use of procaterol inhalation on the health-related QoL, daily activity and shortness of breath in COPD patients with dyspnea in the daily life
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daily activity
Key secondary outcomes QoL, Shortness of Breath, 6-minute walk test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 the group to use the inhalation of procaterol; one month after observational period, inhale one (10 micro gram) or 2 puffs of procaterol before exercise or at dyspnea during the intervention period. Maximum 8 puffs per day.
Interventions/Control_2 the standard therapy group (control group); continue the same therapy as usual without procaterol inhalation for 2 months.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Outpatient with COPD
2. Acquired informed consent
3. Stable patient with more than 3 months of use of thiotropium
4. No bronchial infection nor worsening over last 3 months
5. moderate to severe COPD patient in the GOLD guideline
Key exclusion criteria 1.Patient with obvious bronchial asthma
2.Patient with home oxygen theraphy
3.Patient who were prohibited for procaterol
4.Unappropriate patient judged by the physician.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Suzuki
Organization Niigata University
Division name Medical and dental hospital
Zip code
Address 1-754 Ashahimachi-dori, Chuou-ku, Niigata
TEL 05-227-2200
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Nakayama
Organization Niigata University
Division name Medical and dental hospital
Zip code
Address
TEL
Homepage URL
Email hidenaka@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization the internal funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sado General Hospital
Nishi-Niigata Central Hospital
Niigata Rinko Hospital
Nagaoka Central General Hospital
Nagaoka Red Cross Hospital
Muikamchi Hospital
Joetsu General Hospital
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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 31 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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Fourty three patients were enrolled and 36 completed the protocol. More participants were needed to enroll.

Management information
Registered date
2009 Year 03 Month 31 Day
Last modified on
2011 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002191

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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