UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005756 |
|---|---|
| Receipt number | R000006804 |
| Scientific Title | Clinical trial for the effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia. |
| Date of disclosure of the study information | 2011/06/13 |
| Last modified on | 2016/12/13 22:09:39 |
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Basic information
Public title
Clinical trial for the effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.
Acronym
The effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.
Scientific Title
Clinical trial for the effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.
Scientific Title:Acronym
The effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether the beta-receptor polymorphism affects to hypokalemia occurred after the Formoterol inhalation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum potassium level after the Formoterol inhalation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
long acting beta agonist; Formoterol
Interventions/Control_2
Formoterol/ Budesonide complex
Interventions/Control_3
placebo
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The cases with a genetic polymorphism that results in homozygosity for arginine (Arg/Arg), or glycine (Gly/Gly), at aminoacid residue 16 of the beta2-adrenergic receptor.
The cases with normal range of serum potassium levels.
Key exclusion criteria
Take any drugs.
Hypertension; Systolic pressure >160mmHg or diastolic blood pressure >90mmHg or heart rate> 85 a minute
Past history of hypertension, heart failure, atrial fibrillation, and extrasystole arrythmia.
Abnormalities of ECG ; QTc>0.45s
Pointed out of the hepatic or renal functional abnormality, and diabetes.
Cigarette smoker.
Postsurgery of the lung.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikkou HIGASHIMOTO |
Organization
Kagoshima university Graduate school of medical and dental sciences
Division name
pulmonary medicine
Zip code
Address
8-35-1 Sakuragaoka Kagoshima, Japan
TEL
0992657164
ikkou@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikkou Higashimoto |
Organization
Kagoshima university Graduate school of medical and dental science
Division name
Department of pulmonary medicine
Zip code
Address
8-35-1Sakuragaoka Kagoshima city, Japan
TEL
0992756481
Homepage URL
ikkou@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of pulmonary medicine, Kagoshima university Graduate school of medical and dental sciences
Institute
Department
Personal name
Funding Source
Organization
none
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
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 13 | 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
| 2010 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
Management information
Registered date
| 2011 | Year | 06 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006804
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
