Efficacy and safety of once-daily single-Inhaler TRiple (Trelegy Ellipta) therApy for Japanese with mild to moderate COPD in Kyushu (TRACK study)

JRCT ID: jRCTs071210124

Registered date:02/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild to moderate COPD
• Date of first enrollment: 04/03/2022
• Target sample size: 668
• Study type: Interventional

Intervention(s)

Triple therapy group: Inhale 100 ug of fluticasone, 62.5 ug of umeclidinium and 25 ug of vilanterol once daily for 24 weeks with an ellipta inhaler.
Combination therapy group: Inhale 62.5 ug of umeclidinium and 25 ug of vilanterol once daily for 24 weeks.

Outcome(s)

• Primary Outcome: Average change in trough FEV1 after 12 weeks of treatment from baseline

Secondary Outcome

Subjects who improve by 2 points or more or 4 points or more after 24 weeks of treatment using the minimum clinically significant change in the CAT score or the total score of SGRQ are considered to be effective patients (effective persons).
Find out the percentage of effective persons.

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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 [32, 33] after administration of short-acting beta2 agonist (SABA).
5.Patients without a history of severe exacerbations in the last 12 months.
6.Prescription of LAMA or LABA alone monotherapy, or treatment naive
Gender and smoking history do not matter. Non-smokers, passive smokers, former smokers and current smokers can all be registered.

Exclude 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, beta2-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.(Contraindications to the use of each drug follow the package inserts.)
10. Patients taking any investigational drug/ clinical study drug treatment within 30 days prior to Visit 1(Screening).
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. Patients who are judged to be inappropriate by the investigator or sub-investigator based on the package insert of the target drugs.

Related Information

• Primary Sponsor: Hiromasa Inoue
• Source(s) of Monetary Support: GlaxoSmithKline K.K.