Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
48 participants
INTERVENTIONAL
2024-02-29
2025-01-23
Brief Summary
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* 1 moderate exacerbation in the previous year
* CAT≥10 despite current treatment with LABA -LAMA
* Blood eosinophil levels of ≥150 cells/ml
the investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).
The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.
1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Trelegy
Trelegy commercial product. 1 inhalation daily for 12 months
Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Product to be used according to specifications. 1 inhalation daily for 12 months
LABA-LAMA
Any LABA-LAMA combination approved in Spain is accepted. To be used according to product specifications for 12 months.
Brimica
As per product specifications
Duaklir
As per product specifications
Ultibro
As per product specifications
Ulunar
As per product specifications
Xoterna
As per product specifications
Anoro
As per product specifications
Laventair
As per product specifications
Spiolto Respimat
As per product specifications
Yanimo
As per product specifications
Foradil
As per product specifications
Broncoral
As per product specifications
Formoterol stada
As per product specifications
Oxis
As per product specifications
Formatris
As per product specifications
Formoterol Aldo
As per product specifications
Onbrez
As per product specifications
Oslif
As per product specifications
Hirobriz
As per product specifications
Striverdi
As per product specifications
Beglan
As per product specifications
Betamican
As per product specifications
Inaspir
As per product specifications
Serevent
As per product specifications
Soltel
As per product specifications
Eklira
As per product specifications
Bretaris
As per product specifications
Seebri
As per product specifications
Tovanor
As per product specifications
Enurev
As per product specifications
Spiriva
As per product specifications
Tavulus
As per product specifications
Sirkava
As per product specifications
Braltus
As per product specifications
Gregal
As per product specifications
Incruse
As per product specifications
Rolufta
As per product specifications
Interventions
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Trelegy Ellipta 100/62.5/25Mcg Inh 30D
Product to be used according to specifications. 1 inhalation daily for 12 months
Brimica
As per product specifications
Duaklir
As per product specifications
Ultibro
As per product specifications
Ulunar
As per product specifications
Xoterna
As per product specifications
Anoro
As per product specifications
Laventair
As per product specifications
Spiolto Respimat
As per product specifications
Yanimo
As per product specifications
Foradil
As per product specifications
Broncoral
As per product specifications
Formoterol stada
As per product specifications
Oxis
As per product specifications
Formatris
As per product specifications
Formoterol Aldo
As per product specifications
Onbrez
As per product specifications
Oslif
As per product specifications
Hirobriz
As per product specifications
Striverdi
As per product specifications
Beglan
As per product specifications
Betamican
As per product specifications
Inaspir
As per product specifications
Serevent
As per product specifications
Soltel
As per product specifications
Eklira
As per product specifications
Bretaris
As per product specifications
Seebri
As per product specifications
Tovanor
As per product specifications
Enurev
As per product specifications
Spiriva
As per product specifications
Tavulus
As per product specifications
Sirkava
As per product specifications
Braltus
As per product specifications
Gregal
As per product specifications
Incruse
As per product specifications
Rolufta
As per product specifications
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 40-80 yrs. of age
* Current/former smokers ≥10 pack-year
* Diagnosis of COPD according to GOLD 2023 (post-bronchodilator(BD) FEV1/FVC\<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value
* B+ phenotype
* CAT≥10 despite being on LABA-LAMA for ≥3 months, and
* 1 moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and
* ≥150 blood Eos/ μL (as determined by a single Eos measurement in the previous 12 months available in the medical record of the patient)
* A signed and dated written informed consent prior to study participation.
Exclusion Criteria
* ICS treatment (or oral steroid for whatever reason) during the last 8 weeks (10)
* ECOPD during the last 8 weeks
* Current diagnosis of asthma or documented history of asthma in the medical record of the patient according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines
* Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm)
* Use of domiciliary long-term oxygen therapy or non-invasive ventilation
* Alpha-1 antitrypsin deficiency
* Unstable or life-threatening cardiac disease, including:
* Myocardial infarction or unstable angina in the last 6 months
* Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months.
* New York Heart Association (NYHA) Class IV Heart failure.
* Participation on Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study.
* Long term antibiotic therapy (antibiotics are allowed for the short-term treatment of an exacerbation or for short term treatment of other acute infections during the study).
* Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study).
* Active neoplasm
* Life expectancy \< 1 yr.
* Current participation in other RCTs (randomized clinical trial)
* Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures.
* Any disease, disability, or geographic location that would limit compliance for scheduled visits.
* Known allergy to Trelegy® components (vilanterol, umeclidinium and/or fluticasone furoate) or inability to use the Ellipta® device.
* Women who are pregnant or lactating or are planning to become pregnant during the study.
40 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Fundacio Privada Mon Clinic Barcelona
OTHER
Responsible Party
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Principal Investigators
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Àlvar Agustí
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clínic Barcelona
Barcelona, Catalonia, Spain
Countries
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Other Identifiers
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2023-507304-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANTES B+
Identifier Type: -
Identifier Source: org_study_id
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