UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of gene polymorphisms with lung function decline in patients with asthma on inhaled corticosteroids
Title of the study (Brief title)	Association of gene polymorphisms with lung function decline in asthma
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Treatment with inhaled corticosteroids (ICS) has improved disease control and lung function decline in patients with asthma. However, in some patients, decline in lung function progresses despite the use of ICS. An objective of this study is to clarify genetic factors related to excessive lung function decline in patients with asthma on ICS treatment.
Basic objectives2	Others
Basic objectives -Others	To clarify polymorphisms of genes that could be associated with excessive lung function decline and asthma severity in asthmatic patients on ICS treatment.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between polymorphsims of candidate genes and annual decline of FEV1
Key secondary outcomes	Association of levels of serum markers, and asthma control with annual decline of FEV1. Association of polymorphisms of candidate genes with levels of serum markers and asthma control

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with stable asthma at least 1 month apart from exacerbations that need rescue bronchodilators or systemic corticosteroids. Patients with asthma who have 3 or more records of pre-or post-bronchodilator FEV1 values obtained during 3 or more years. The first spirometric data was obtained when patients were 25 yr old or more and had been treated with ICS for 1 or more years.
Key exclusion criteria	Current smokers or ex smokers with 10 or more pack-years when the first spirometric data was taken. Patients with respiratory diseases other than asthma such as Churg Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, congestive heart disease, vocal cord dysfunction, interstitial pneumonia, bronchiectasia. Patients who are not adherent to ICS treatment (determined by physicians).
Target sample size	300

Research contact person
Name of lead principal investigator	Hisako Matsumoto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Email	hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hisako Matsumoto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Homepage URL
Email	hmatsumo@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Univs: Osaka City, Kanazawa, Kinki, Kobe, Shiga Med Science, Mie, Kochi, Hiroshima, Fujita Health; Hps & Clin: Kobe General, Kobe West, Sakai, Hiroshima All & Resp; Nat. Inst. Public Health; RIKEN Inst.
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	2009 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 28 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	-Kanemitsu Y, Matsumoto H, Izuhara K, Tohda Y, Kita H, Horiguchi T, et al. Increased periostin associates with greater airflow limitation in patients receiving inhaled corticosteroids. J Allergy Clin Immunol 2013;132:305-312 e303. -Nagasaki T, Matsumoto H, et al. Integrating longitudinal information on pulmonary function and inflammation using asthma phenotypes. J Allergy Clin Immunol. 133:1474-77 e2.2014 -Nagasaki T, Matsumoto H, et al. Using exhaled nitric oxide and serum periostin as a composite marker to identify severe steroid-insensitive asthma. Am J Respir Crit Care Med. 190:1449-52.2014 -Sunadome H, et al. IL4Ra and ADAM33 as genetic markers in asthma exacerbations and type-2 inflammatory endotype. Clin Exp Allergy, in press -Matsumoto H, et al. Staphylococcus aureus enterotoxin sensitization involvement and its association with CysLTR1 variant in different asthma phenotypes. Ann Allergy Asthma Immunol 2017, 118:197-203.
Other related information	examine retrospectively 3 or more years, and prospectively 0.5 or more years.

Management information
Registered date	2009 Year 08 Month 31 Day
Last modified on	2017 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002784