UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046812 |
|---|---|
| Receipt number | R000053414 |
| Scientific Title | Efficacy and safety of once-daily single-Inhaler TRiple(Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2025/02/05 14:36:15 |
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Basic information
Public title
Efficacy and safety of once-daily single-Inhaler TRiple(Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu
Acronym
TRACK study
Scientific Title
Efficacy and safety of once-daily single-Inhaler TRiple(Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu
Scientific Title:Acronym
TRACK study
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To investigate the safety and efficacy of triple therapy on lung function and health-related QOL in patients with mild to moderate COPD when compared with LAMA/LABA combination therapy.
2. To identify baseline characteristics and biomarkers to predict responders and non-responders to triple therapy in patients with mild to moderate COPD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the trough FEV1 on treatment 12-weeks from baseline
Key secondary outcomes
Responder rate based on the CAT Score (decreasing of minimum clinically important deterioration [MCID] >=2 points as a responder) and on the SGRQ Total Score (decreasing of MICD >=4 points as a responder) at treatment 24-weeks from baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Trelegy100 (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate 100mcg/62.5mcg/25mcg) once a day via ellipta dry powder inhaler.
Interventions/Control_2
Anoro (Umeclidinium Bromide/Vilanterol Trifenatate 62.5mcg/25mcg) once a day via ellipta dry powder inhaler.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. 40 years old and over
2. Mild to moderate COPD
3. Impairments of QOL (>=7 points of total COPD assessment test [CAT] score)
4. Airflow obstruction <0.7 of an FEV1/FVC ratio and %FEV1 predicted >50% assessed by Japanese Respiratory Society (JRS) criteria after administration of short-acting beta2 agonist
5. Patients without a history of severe exacerbations in the last 12 months
6. Prescription of LAMA or LABA alone monotherapy, or treatment naive
Key exclusion criteria
1. Women of childbearing potential. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
2. Patients with a current diagnosis of asthma.(However, those patients with a prior history of asthma are eligible if they have a current diagnosis of COPD, and patients with ACO-like features, namely those whose condition will be partially met to the conditions defined for ACO in JRS guidance, may be included).
3. Patients who cannot perform lung function tests
4. Patients who had acute respiratory tract infection (e.g. pneumonia) or moderate/severe COPD exacerbation within 4 weeks at the screening
5. Severe or unstable other comorbid diseases
6. Active respiratory infections or malignancies
7. Other chronic respiratory diseases (bronchiectasis, interstitial pneumonias, pneumoconiosis)
8. Patients who cannot use any inhalation devices
9. Past history of severe side effects or history of allergy/hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta 2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation.
10. Participants taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t1/2) of the prior investigational study (whichever is the longer of the two).
11. Patients who are recognized as inappropriate subjects in the study by physicians (eg, dementia, psychological disorders, cerebrovascular diseases with palsy, etc), because we will get informed consents by patients themselves and will not set other gardiners or proxies for informed consents.
12. Other patients who are considered inappropriate according to the package inserts of both target drugs.
Target sample size
668
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Inoue |
Organization
Kagoshima University
Division name
Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima-city, Kagoshima
TEL
099-275-6481
inoue@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Takahashi |
Organization
Saga university hospital
Division name
Respiratory medicine
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga
TEL
0952342360
Homepage URL
takahak@cc.saga-u.ac.jp
Sponsor or person
Institute
Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline plc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of Saga University Hospital
Address
5-1-1, Nabeshima
Tel
0952-34-3400
crb@mail.admin.saga-u.ac.jp
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
熊本大学病院（熊本県）
熊本市医師会 熊本地域医療センター（熊本県）
熊本市立熊本市民病院（熊本県）
琉球大学病院（沖縄県）
社会医療法人 友愛会 友愛医療センター（沖縄県）
大分大学医学部附属病院（大分県）
独立行政法人国立病院機構大分医療センター（大分県）
長崎大学病院（長崎県）
独立行政法人 地域医療機能推進機構 諫早総合病院（長崎県）
福岡大学病院（福岡県）
福岡大学筑紫病院（福岡県）
医療法人社団 高邦会 福岡山王病院（福岡県）
宮崎大学医学部附属病院（宮崎県）
独立行政法人 国立病院機構 宮崎東病院（宮崎県）
社会医療法人 泉和会 千代田病院（宮崎県）
鹿児島大学病院（鹿児島県）
鹿児島市立病院（鹿児島県）
公益社団法人 昭和会 いまきいれ総合病院（鹿児島県）
公益社団法人 鹿児島共済会 南風病院（鹿児島県）
鹿児島厚生連病院（鹿児島県）
医療法人 青仁会 池田病院（鹿児島県）
佐賀大学医学部附属病院（佐賀県）
地方独立行政法人 佐賀県医療センター 好生館（佐賀県）
独立行政法人 地域医療機能推進機構 佐賀中部病院（佐賀県）
独立行政法人 国立病院機構 東佐賀病院（佐賀県）
産業医科大学病院（福岡県）
医療法人社団恵友会 霧ヶ丘つだ病院（福岡県）
久留米大学病院（福岡県）
独立行政法人 国立病院機構 九州医療センター（福岡県）
公立八女総合病院（福岡県）
社会福祉法人恩賜財団済生会支部 福岡県済生会二日市病院（福岡県）
医療法人 清和会 長田病院（福岡県）
九州大学病院（福岡県）
公立学校共済組合九州中央病院（福岡県）
独立行政法人 国立病院機構 福岡東医療センター（福岡県）
独立行政法人 国立病院機構 福岡病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053414
