UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002414 |
|---|---|
| Receipt number | 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 19:54:03 |
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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
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
hmatsumo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002784
