UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial for the effect of beta2 adrenargic receptor polymorphism to long acting beta agonist induced hypokalemia.
Title of the study (Brief title)	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	Ikkou HIGASHIMOTO
Organization	Kagoshima university Graduate school of medical and dental sciences
Division name	pulmonary medicine
Address	8-35-1 Sakuragaoka Kagoshima, Japan
TEL	0992657164
Email	ikkou@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Ikkou Higashimoto
Organization	Kagoshima university Graduate school of medical and dental science
Division name	Department of pulmonary medicine
Address	8-35-1Sakuragaoka Kagoshima city, Japan
TEL	0992756481
Homepage URL
Email	ikkou@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Department of pulmonary medicine, Kagoshima university Graduate school of medical and dental sciences
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006804