UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019118 |
|---|---|
| Receipt number | R000021938 |
| Scientific Title | Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80% |
| Date of disclosure of the study information | 2015/09/25 |
| Last modified on | 2017/01/18 21:35:26 |
* 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
Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Acronym
Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Scientific Title
Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Scientific Title:Acronym
Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Region
| Japan |
Condition
Condition
Japanese COPD patients with %FEV1>=80%
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and safety of formoterol in japanese COPD patients with %FEV1>=80%
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is change from baseline FEV1 to the end of tratment period in FEV1 60-min post-dose.
Key secondary outcomes
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
Patients receives inhaled formoterol 9 micro g twice daily via turbuhaler for 12 weeks
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
Male and female patients >= 40 years of age with a clinical diagnosis of COPD (post-bronchodilator FEV1 >= 80% of predicted norma, and post-bronchodilator FEV1/FVC < 70%) are eligible for inclusion. Patients are also required to have a crrent or previous smoking history of >= 10 pack-years.
Key exclusion criteria
Key exclusion criteria ware: a history or current clinical diagnosis of asthma or atopic disease such as allergic rhinitis; positive to specific IgE for environmental allergens; positive results of a methacholine inhalation challenge (<10,000 micro g/ml); use of long acting beta2-aganist, long acting muscarinic antagonist, theophylline, inhaled/oral/intravenous steroid, leukotriene receptor antagonist; sensitivity to the study drug; poor inhalation technique of the study drug; exhaled nitric oxide over 22 ppb in ex smoker or 18 ppb in current smoker (NIOX MINO); respiratory infection or respiratory tract disorder other than COPD; unstable ischemic heart disease or any other relevant cardiovascular disorder; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kasahara |
Organization
Kanazawa University Hospital
Division name
Respiratory Medicine
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2000
kasa1237@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Johsuke Hara |
Organization
Cellular Transplantation Biology, Kanazawa University Graduate School of Medicine
Division name
Respiratory Medicine
Zip code
Address
13-1 Takara-machi Kanazawa Ishikawa
TEL
076-265-2276
Homepage URL
hara0728@gmail.com
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Medicine, Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2015 | Year | 09 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | 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
| 2015 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
