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Aclidinium Bromide

Clinical trials investigating Aclidinium Bromide are studying treatment options for people with chronic obstructive pulmonary disease (COPD). These studies look at how well different inhaled therapies work, especially for improving clinical control and comparing combination treatments in higher-risk patients.

Table of contents

Overview of the trial data

The trial data for Aclidinium Bromide describes one completed study in people with Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes breathing difficult.[1] The study asks whether one inhaled treatment plan works better than another for improving clinical control in patients with COPD.[1]

Study design and phase

This was an interventional study, which means researchers assigned treatments and compared the results between groups.[1] It was also an open-label, pragmatic, randomized, and controlled trial in Phase 3.[1] Phase 3 studies usually involve larger groups and are designed to compare how well treatments work in practice.[1]

Who the trial is for

The main target group was high-risk GOLD B patients with COPD.[1] GOLD B is a COPD category used to describe a specific patient group in the study, and “high-risk” means the patients may need closer treatment control.[1] The trial enrolled 1,028 participants, showing that it was a fairly large comparison study.[1]

Treatments compared in the study

The study compared Trelegy® with LABA-LAMA treatment to see which option gave better clinical control.[1] LABA-LAMA means a combination of two long-acting inhaled medicines, and the trial data lists many branded inhaled products used in these treatment groups.[1] The source data does not give a full breakdown of all randomization groups, but it clearly shows a comparison between Trelegy® and LABA-LAMA-based care.[1]

Main outcome measured

The main outcome was whether a patient stayed persistently controlled at all study visits.[1] To count as controlled, the patient had to meet the study criteria at month 3, 6, 9, and 12.[1] The trial also used a validated composite endpoint, which means the result combined more than one important measure, including the domains called stability and impact.[1]

What the study result means for patients

This trial was designed to find out whether one inhaled treatment strategy could improve daily disease control in COPD better than another.[1] Because the study is completed, it adds evidence about treatment comparison in a real-world style setting for patients with COPD.[1] The data shown here is focused on treatment effectiveness and control over time, not on basic drug science.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2023-507304-32-00Phase 3Chronic Obstructive Pulmonary DiseaseCompleted1028

FAQ

  • What is being studied in clinical trials with Aclidinium Bromide? The trials focus on treatment strategies for COPD, especially how different inhaled combinations perform. The main goal is to see whether one treatment gives better clinical control than another.
  • Who are the target patients in these studies? The study data focuses on patients with chronic obstructive pulmonary disease, especially high-risk GOLD B patients. This means the trials are looking at people with COPD who may need closer treatment control.
  • What phase is the main trial of Aclidinium Bromide in? The main trial listed is a Phase 3 study. Phase 3 trials usually compare treatments in larger groups to see how well they work in real clinical practice.
  • What outcome is the trial measuring? The main outcome is persistent clinical control at all study visits. Patients must meet the control criteria at month 3, 6, 9, and 12 to be counted as controlled.
  • How many people were enrolled in the trial? The trial enrolled 1,028 participants. This gives the study enough people to compare the treatment groups.

Sperimentazioni cliniche in corso su Aclidinium Bromide

  • Studio sull’efficacia di umeclidinio bromuro, fluticasone furoato e vilanterolo per il controllo della BPCO nei pazienti ad alto rischio

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

Glossario

  • Chronic Obstructive Pulmonary Disease (COPD): A long-term lung disease that makes breathing harder. It is the main condition studied in the trial data.
  • GOLD B: A COPD patient group used for study classification. In this trial, the focus is on high-risk GOLD B patients.
  • High-risk: A group of patients who may have a greater chance of poor disease control or worse outcomes.
  • Phase 3: A later stage of clinical research where treatments are tested in larger groups to compare how well they work.
  • Interventional study: A study where researchers give one or more treatments and compare the results.
  • Randomized: Patients are assigned by chance to different treatment groups. This helps make the comparison fair.
  • Controlled trial: A study that compares one treatment with another treatment or group.
  • Open-label: A study design where patients and researchers know which treatment is being given.
  • Pragmatic trial: A study designed to reflect everyday medical practice as closely as possible.
  • Clinical control (CC): A combined measure used in the study to judge how well COPD is controlled over time.
  • Composite endpoint: A study result made from more than one measure. Here it includes the domains called stability and impact.

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