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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002414
Receipt No. R000002784
Scientific Title Association of gene polymorphisms with lung function decline in patients with asthma on inhaled corticosteroids
Date of disclosure of the study information 2009/09/01
Last modified on 2017/03/29

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Basic information
Public title Association of gene polymorphisms with lung function decline in patients with asthma on inhaled corticosteroids
Acronym Association of gene polymorphisms with lung function decline in asthma
Scientific Title Association of gene polymorphisms with lung function decline in patients with asthma on inhaled corticosteroids
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisako Matsumoto
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
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
1st name
Middle name
Last name Hisako Matsumoto
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.


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 Completed
Date of protocol fixation
2009 Year 01 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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