UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001833 |
|---|---|
| Receipt number | 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 | 2021/09/17 08:41:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hidenaka@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
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.
Management information
Registered date
| 2009 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.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 |
