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利用者名:
UMIN ID:

試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000042690
受付番号 R000048718
科学的試験名
一般公開日(本登録希望日) 2020/12/10
最終更新日 2020/12/10

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Using a tracker incorporated into Budesonide/Formoterol turbuhaler to improve asthma control: a randomized controlled study
一般向け試験名略称/Acronym
Turbuhaler tracker assisted asthma control
科学的試験名/Scientific Title
The application of Budesonide/Formoterol turbuhaler with a tracker to improve asthma control in moderate to severe asthmatics: a randomized controlled study
科学的試験名略称/Scientific Title:Acronym
BUD/FOR turbuhaler with a tracker to improve asthma control
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Patients with moderate to severe asthma with/without turbuhaler-incorporated tracker to assist asthma control
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To compare the asthma control outcomes (changes of fractional exhaled nitric oxide [FeNO], scores of asthma control test [ACT], lung function parameters, acute exacerbation rates, ect.) treated with Budesonide/Formoterol turbuhaler in the presence or absence of Dubaobao tracker in patients with moderate to severe asthma
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
To observe the dose and timing of controller inhaler use through the tracker-Dubaobao, and correlate the inhaler adherence recorded by the tracker with clinical outcomes
試験の性質1/Trial characteristics_1 その他/Others
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Treatment difference (post- minus pre-treatment) of FeNO between the tracker and usual care groups
副次アウトカム評価項目/Key secondary outcomes
Any one of the following conditions are estimated and regarded as secondary objectives: Changes from baseline on ACT score, FeNO, lung function, blood parameters within the same group; Treatment difference (post- minus pre-treatment) on ACT, lung function, blood parameters between the 2 groups; Electronic record of numbers and patterns of inhaler use; Correlation between inhaler use and asthma outcomes (symptoms worsening, any exacerbation, severe exacerbation); Annualized rate of severe exacerbations

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Budesonide/Formoterol tubuhaler with Dubaobao tracker (160/4.5 mcg per puff, 1 to 2 puffs twice daily plus as needed for 24 weeks)
介入2/Interventions/Control_2
Budesonide/Formoterol tubuhaler without Dubaobao tracker (160/4.5 mcg per puff, 1 to 2 puffs twice daily plus as needed for 24 weeks)
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Patients are considered eligible to enroll if they meet all of the following criteria: 1. Aged from 20 to 80 years. 2. Documented asthma history greater than 6 months before enrollment. 3. Patients who are in need of GINA step 3 to step 5 treatment at enrollment (on low to high dose inhale d corticosteroid/long-acting beta2 agonist with or without concurrent use of other asthma controllers, e.g. tiotropium, leukotriene receptor antagonist [LTRA] etc.). 4. Use of BUD/FOR for at least 4 weeks before enrollment.
除外基準/Key exclusion criteria
Patients who meet any one of the following criteria will be excluded: 1. Hypersensitivity to BUD/FOR. 2. Had lower respiratory tract infections or received systemic steroid 4 weeks before enrollment. 3. Smoking history greater than 20 pack-years. 4. The onset of respiratory symptoms after the age of 40 years in current or previous smokers with a smoking history greater than 10 pack-years. 5. COPD, clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 6. A chest X-ray indicating diagnosis other than asthma that might interfere with the study. 7. Alcohol or medication abuse. 8. Pregnant woman. 9. Unable or unwilling to sign permit.
目標参加者数/Target sample size 74

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Kang-Cheng
ミドルネーム
Su
所属組織/Organization
Taipei Veterans General Hospital
所属部署/Division name
Department of Chest Medicine
郵便番号/Zip code 11217
住所/Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
電話/TEL +886-2-28712121-3152
Email/Email kcsu@vghtpe.gov.tw

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Kang-Cheng
ミドルネーム
Su
組織名/Organization
Taipei Veterans General Hospital
部署名/Division name
Department of Chest Medicine
郵便番号/Zip code 11217
住所/Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
電話/TEL +886-2-28712121-3152
試験のホームページURL/Homepage URL
Email/Email kcsu@vghtpe.gov.tw

実施責任組織/Sponsor
機関名/Institute その他 Taipei Veterans General Hospital
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Taipei Veterans General Hospital
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization
Taiwan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Taipei Veterans General Hospital
住所/Address
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan
電話/Tel +886-2-28757384
Email/Email irbopinion@vghtpe.gov.tw

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs はい/YES
試験ID1/Study ID_1 200620
ID発行機関1/Org. issuing International ID_1
2020-07-016B
試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 12 10

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2020 06 20
倫理委員会による承認日/Date of IRB
2020 07 25
登録・組入れ開始(予定)日/Anticipated trial start date
2021 01 01
フォロー終了(予定)日/Last follow-up date
2024 12 31
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 12 08
最終更新日/Last modified on
2020 12 10


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048718
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048718

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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