Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Trelegy100 (Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate 100mcg/62.5mcg/25mcg) once a day via ellipta dry powder inhaler.
Anoro (Umeclidinium Bromide/Vilanterol Trifenatate 62.5m
Sponsors
Kagoshima university
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the trough FEV1 on treatment 12-weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKoichiro Takahashi
Saga university hospital Respiratory medicine
Outcome results
None listed