Study on the Effectiveness of Beclometasone, Glycopyrronium, and Formoterol in COPD Patients with Asthma Characteristics

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for people with Chronic Obstructive Pulmonary Disease (COPD), a lung condition that makes it hard to breathe. The study is particularly interested in patients who have characteristics of both COPD and asthma. The treatment being tested is called “triple therapy,” which includes three types of medications: an inhaled corticosteroid (ICS), a long-acting beta-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). These medications are used to help open up the airways in the lungs and reduce inflammation, making it easier to breathe.

The purpose of the study is to see how well this triple therapy works compared to a “dual therapy,” which includes only the LABA and LAMA medications. The study will look at how these treatments affect the health status of patients over a period of 26 weeks. Patients will be divided into groups, with some receiving the triple therapy and others receiving the dual therapy. The study will measure changes in health status using a tool called the Clinical COPD Questionnaire (CCQ), which helps to assess how the disease affects daily life.

During the study, patients will use their assigned inhalation treatments, which may include combinations like Formoterol and Aclidinium Bromide, Glycopyrronium Bromide, Beclometasone Dipropionate, Tiotropium, Olodaterol, Umeclidinium Bromide, and Vilanterol. The study aims to find out if the triple therapy can lead to a significant improvement in the health status of patients compared to the dual therapy. The results will help determine the best treatment approach for managing COPD in patients with asthma-like characteristics.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Chronic Obstructive Pulmonary Disease (COPD), and other health indicators.

Participants must be 40 years or older, have a physician diagnosis of COPD, and meet other health-related criteria.

2 initial assessment

An initial assessment is conducted to document the current health status using the Clinical COPD Questionnaire (CCQ).

This assessment helps establish a baseline for measuring changes in health status throughout the trial.

3 treatment allocation

Participants are randomly assigned to one of two treatment groups: the triple therapy group or the dual therapy group.

The triple therapy includes inhalation of medications containing formoterol, glycopyrronium bromide, and beclometasone.

The dual therapy involves inhalation of medications containing formoterol and glycopyrronium bromide.

4 treatment administration

Participants administer the assigned inhalation treatment daily for a period of 26 weeks.

The frequency and dosage are determined by the study protocol and are monitored throughout the trial.

5 ongoing monitoring

Regular monitoring of health status is conducted using the CCQ to track any changes or improvements.

Participants may be required to attend follow-up visits to ensure adherence to the treatment and to address any concerns.

6 final assessment

At the end of the 26-week period, a final assessment is conducted to evaluate the effectiveness of the treatment.

The primary outcome is the improvement in health status, measured by a change of 0.4 or more on the CCQ.

Who Can Join the Study?

You must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD). This means your doctor has confirmed you have this lung condition, either through past records or by testing your breathing during the first study visit.
You need to be 40 years old or older.
You should have symptoms of COPD. This is determined by a score of 1 or higher on a questionnaire called the Clinical COPD Questionnaire (CCQ), which measures how COPD affects your health.
You must not have used any inhaled corticosteroids (ICS) in the past 12 months. These are medications often used to reduce inflammation in the lungs.
You should be using a long-acting bronchodilator. This could be either a single LABA (long-acting beta-agonist) or LAMA (long-acting muscarinic antagonist), both of which help open the airways in your lungs. You can also use a combination inhaler that includes both LABA and LAMA. Additionally, you are allowed to use a short-acting bronchodilator, which provides quick relief from breathing difficulties.
Your blood test should show eosinophils (a type of white blood cell) at a level of 100 cells per microliter or more. You should also have one or more characteristics of asthma as defined by the GOLD 2019 guidelines, which are standards for diagnosing and managing lung diseases.

Who Cannot Join the Study?

Patients who have a different lung condition other than Chronic Obstructive Pulmonary Disease (COPD).
Patients who have been previously treated with ICS (inhaled corticosteroids) for their COPD.
Patients who do not have characteristics of asthma as defined by GOLD 2019 guidelines.
Patients with blood eosinophil counts lower than 100 cells per microliter. Eosinophils are a type of white blood cell involved in the body’s immune response.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Site Name	City	Country	Status
Gbmwpob Pljdcuwjkwned Rdiyucdx Igrgeyjfd Bxfp	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.02.2020

Trial locations

Investigated drugs:

ICS/LABA/LAMA is a combination therapy used in the treatment of COPD (Chronic Obstructive Pulmonary Disease) with characteristics of asthma. This therapy includes an inhaled corticosteroid (ICS), a long-acting beta-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). The ICS helps reduce inflammation in the airways, the LABA helps relax the muscles around the airways to improve breathing, and the LAMA helps keep the airways open by blocking certain receptors. This triple therapy is being studied for its effectiveness in improving the health status of patients who have not previously used inhaled corticosteroids.

LABA/LAMA is a dual therapy used for managing COPD. It combines a long-acting beta-agonist (LABA) and a long-acting muscarinic antagonist (LAMA). The LABA component works by relaxing the muscles around the airways, making it easier to breathe, while the LAMA component helps keep the airways open by blocking specific receptors. This therapy is being compared to the triple therapy to see which is more effective in improving the health status of COPD patients with asthma-like characteristics.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that causes breathing difficulties due to airflow blockage. It typically progresses slowly, with symptoms such as chronic cough, mucus production, and shortness of breath worsening over time. The disease is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. As COPD advances, individuals may experience increased breathlessness, frequent respiratory infections, and fatigue. The condition can lead to decreased physical activity and quality of life. COPD is characterized by episodes of exacerbations, where symptoms suddenly worsen, often requiring medical attention.

Trial ID:

2023-508300-37-00

Protocol code:

GPRI-19102-TRA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Beclometasone, Glycopyrronium, and Formoterol in COPD Patients with Asthma Characteristics

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?