UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Factors affecting the Long-term Asthma Therapy (FLOAT)
Title of the study (Brief title)	FLOAT study
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Medicine in general Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the individual factors affecting the asthma outcomes in patients with controlled asthma
Basic objectives2	Others
Basic objectives -Others	To assess the relationship with the progression of airway obstruction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Determinants of progression of airway obstruction
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	25 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Controlled asthma according to the GINA global guidelines
Key exclusion criteria	Current smoker Comorbid with other pulmonary disease Poor adherence to asthma treatent
Target sample size	150

Research contact person
Name of lead principal investigator	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0619
Email	kazmatsu@wakayama-med.ac.jp

Public contact
Name of contact person	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama
TEL	073-441-0619
Homepage URL
Email	kazmatsu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 31 Day
Anticipated trial start date	2013 Year 06 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	Published
URL releasing results
Results
Other related information	To determine the individual factors that associated with progression of airway obstruction in controlled asthma

Management information
Registered date	2013 Year 10 Month 23 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014147