Study Comparing Trelegy with LABA-LAMA Drug Combination for Improving COPD Control in High-Risk Patients

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What is this study about?

The study focuses on patients with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The trial aims to compare two treatments to see which is more effective in improving the health of patients with a specific type of COPD known as GOLD B+. One treatment is called Trelegy, which is a combination of three medications, and the other is a combination of two types of medications known as LABA-LAMA. The purpose of the study is to determine which treatment better helps patients maintain stable health and manage their symptoms over time.

Participants in the study will be randomly assigned to receive either Trelegy or the LABA-LAMA combination. The study will last for 12 months, during which participants will have regular check-ups to monitor their health and see how well the treatment is working. The study will look at various aspects of health, such as breathing ability, the need for additional medication, and overall well-being. The goal is to find out if one treatment helps patients stay healthier and avoid worsening of their condition more effectively than the other.

Throughout the study, researchers will collect information on how each treatment affects the participants’ health, including any changes in their ability to breathe and their need for emergency treatments. This information will help doctors understand which treatment might be better for managing COPD in patients with the GOLD B+ type. The study is expected to provide valuable insights into the best ways to help people with this condition live healthier lives.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures.

The patient will provide written consent to participate in the study.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility based on criteria such as age, smoking history, and diagnosis of chronic obstructive pulmonary disease (COPD).

The assessment will include a review of the patient’s medical history and current health status.

3 randomization

The patient will be randomly assigned to one of two treatment groups: triple therapy or LABA-LAMA combination.

This process ensures that each participant has an equal chance of receiving either treatment.

4 treatment administration

The patient will begin the assigned treatment regimen.

For the triple therapy group, the patient will use Trelegy Ellipta, which is an inhalation powder containing fluticasone furoate, umeclidinium, and vilanterol.

For the LABA-LAMA combination group, the patient will use a combination of long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA) medications, such as Ultibro Breezhaler or ANORO ELLIPTA.

5 treatment schedule

The patient will administer the inhalation medication once daily as per the prescribed dosage.

The treatment will continue for a duration of 12 months, with regular follow-up visits.

6 follow-up visits

The patient will attend follow-up visits at months 3, 6, 9, and 12 to monitor health status and treatment effectiveness.

During these visits, assessments will include lung function tests, symptom evaluation, and any side effects experienced.

7 completion of the study

At the end of the 12-month period, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

The study aims to determine the effectiveness of the treatments in improving clinical control in patients with COPD.

Who Can Join the Study?

Must be a female or male.
Must be between 40 and 80 years old.
Must be a current or former smoker with a history of smoking at least 10 pack-years. A pack-year is a way to measure how much someone has smoked over time.
Must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to specific guidelines. This includes a test result where the ratio of two lung function measurements (FEV1/FVC) is less than 0.7 after using a bronchodilator, which is a medicine that helps open the airways.
Must have a B+ phenotype, which means:
- A score of 10 or more on a test called CAT, even after using certain COPD medications (LABA-LAMA) for at least 3 months. CAT is a questionnaire that measures the impact of COPD on a person’s life.
- At least one moderate episode of worsening COPD symptoms in the past year, treated with a short course of oral steroids and/or antibiotics.
- A blood test showing at least 150 eosinophils per microliter. Eosinophils are a type of white blood cell, and this measurement should be available in the patient’s medical record from the past 12 months.
Must provide a signed and dated written informed consent before participating in the study. This means the patient agrees to join the study after understanding what it involves.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have been diagnosed with another serious lung condition besides Chronic Obstructive Pulmonary Disease (COPD).
Patients who have had a recent lung infection or flare-up of their COPD symptoms.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario Rio Hortega	Valladolid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Consorci D’atencio Primaria De Salut Barcelona Esquerra	Barcelona	Spain
Hospital El Bierzo	Ponferrada	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hhuxrfdg Upsnvzzmjdogq Db Lo Pbevmmlw	Madrid	Spain
Hauniidc Uxnmkcbrbbjrp Mswjaqq Do Voqybdpzjc	Santander	Spain
Cfjubn dp Smnrx Fkmcbeo	Fuenlabrada	Spain
Fasgoisgc Pcng La Imyghaaetqkwo Bnynifoef Dlv Hrfiybdc Ucqwbctdmciqu Lj Pnh	Madrid	Spain
Cwobwafc Htqpmytxmndk Ufdffrzdhwtop Dg Vmbb	Vigo	Spain
Hegrqarw Vwws ddvbdiae	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	31.12.2023

Trial locations

Investigated drugs:

Trelegy is a medication used in this trial to help improve breathing in patients with COPD (Chronic Obstructive Pulmonary Disease). It combines three different types of medicines that work together to open up the airways, reduce inflammation, and make breathing easier. This medication is taken once a day using an inhaler.

LABA-LAMA Combination refers to a treatment that combines two types of medications: a Long-Acting Beta Agonist (LABA) and a Long-Acting Muscarinic Antagonist (LAMA). These medications work by relaxing the muscles around the airways and keeping them open for a longer period, which helps improve breathing in COPD patients. This combination is also administered using an inhaler.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease, commonly known as COPD, is a long-term lung condition that makes it difficult to breathe. It is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities. The disease progresses slowly, with symptoms such as chronic cough, sputum production, and shortness of breath worsening over time. COPD is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. As the disease advances, individuals may experience increased frequency and severity of respiratory infections and exacerbations. The progression of COPD can lead to a significant impact on daily activities and quality of life.

Trial ID:

2023-507304-32-00

Protocol code:

ANTES B+

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Trelegy with LABA-LAMA Drug Combination for Improving COPD Control in High-Risk Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?