UMIN-CTR Clinical Trial

Basic information
Public title	Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(Salbutamol) about bronchodilating effect part and onset of relief of dyspnea.
Acronym	Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(salbutamol)about bronchodilating effect part and onset of relief of dyspnea.
Scientific Title	Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(Salbutamol) about bronchodilating effect part and onset of relief of dyspnea.
Scientific Title:Acronym	Comparison study among FM/BUD(Formoterol/Budesonide), SM/FP (Salmeterol/Fluticasone), SB(salbutamol)about bronchodilating effect part and onset of relief of dyspnea.
Region	Japan

Condition
Condition	Adults who were induced bronchoconstriction by methacholine.
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare bronchodilating effect among FM/BUD, SM/FP, SB.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Respiratory impedance, Borg scale
Key secondary outcomes	FEV1.0, Lung capacity

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Formoterol/Budesonide
Interventions/Control_2	Salmeterol/Fluticasone
Interventions/Control_3	Salbutamol
Interventions/Control_4	Control(No treatment)
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Male or female aged between 20 and 40 years. 2.The forced expiratory volume in one second has to at least 70 percent of predicted value.
Key exclusion criteria	1.Aortic aneurysm 2.Pregnancy 3.History of cerebral infarction within three months. 4.Breast-feeding women 5.Hypertension 6.Diabetes mellitus 7.Hyperthyroidism 8.Cardiac disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Atsuta
Organization	Juntendo University
Division name	Respiratory Medicine
Zip code	1138421
Address	3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	0358021063
Email	atsuta@juntendo.ac.jp

Public contact
Name of contact person	1st name Yukinari Middle name Last name Itoigawa
Organization	1978
Division name	Respiratory Medicine
Zip code	3300062
Address	3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5802-1063
Homepage URL
Email	yuitoiga@gmail.com

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
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	Juntendo University
Address	3-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5802-1584
Email	kenkyu5858@juntendo.ac.jp

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	2013 Year 01 Month 01 Day

Related information
URL releasing protocol	N/A
Publication of results	Unpublished

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	11
Results	N/A
Results date posted	2020 Year 06 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	N/A
Participant flow	N/A
Adverse events	N/A
Outcome measures	N/A
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 01 Day
Date of IRB	2012 Year 07 Month 27 Day
Anticipated trial start date	2012 Year 07 Month 27 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	N/A

Management information
Registered date	2012 Year 12 Month 11 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010712