Study on the Effectiveness and Safety of CHF6001 DPI with Roflumilast for Patients with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis
This clinical trial is focused on studying the effects of a new treatment for Chronic Obstructive Pulmonary Disease (COPD), specifically in patients who also have chronic bronchitis. The treatment being tested is called CHF6001 DPI, which is an inhalation powder containing the active substance tanimilast. The study will also involve a medication called Roflumilast (Daliresp®), which is available in tablet form. Some participants will receive a placebo, which looks like the real medication but does not contain any active ingredients.
The purpose of the study is to evaluate how effective and safe two different doses of CHF6001 DPI are when added to the usual maintenance therapy for COPD. This maintenance therapy typically includes a combination of inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA). The study will last for 52 weeks, during which participants will be randomly assigned to different groups. Some will receive CHF6001 DPI along with their regular treatment, while others will receive Roflumilast or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed.
Throughout the study, participants will be monitored to see how the treatments affect their COPD symptoms, particularly the frequency and severity of flare-ups, also known as exacerbations. The study will also assess changes in lung function and quality of life. By the end of the study, researchers hope to determine whether adding CHF6001 DPI to the standard COPD treatment can help reduce the number of moderate and severe exacerbations in patients with COPD and chronic bronchitis.
1joining the study
Upon joining the study, participants are required to provide written informed consent. This confirms understanding of the study procedures and agreement to participate.
Participants must be at least 40 years old and have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis.
2initial assessment
An initial assessment is conducted to confirm eligibility. This includes a review of medical history, smoking history, and current symptoms.
Participants must have a history of at least one moderate or severe COPD exacerbation in the previous year and be on maintenance triple therapy for at least 12 months prior to the screening.
3randomization and treatment allocation
Participants are randomly assigned to one of the treatment groups. This process is double-blind, meaning neither the participants nor the researchers know which treatment is being administered.
The study involves the use of CHF6001 DPI, Roflumilast (Daliresp®) 500µg, and Roflumilast (Daliresp®) 250µg, as well as corresponding placebos.
4treatment administration
Participants receive their assigned treatment for a duration of 52 weeks. CHF6001 DPI is administered via inhalation, while Roflumilast is taken orally in tablet form.
The frequency and dosage depend on the specific treatment group to which the participant is assigned.
5ongoing monitoring and assessments
Throughout the study, participants undergo regular monitoring to assess the efficacy and safety of the treatment. This includes spirometry tests and questionnaires to evaluate symptoms and quality of life.
Participants are required to use electronic devices to complete COPD questionnaires and perform required outcome measurements.
6completion of the study
At the end of the 52-week period, participants complete a final assessment to evaluate the overall impact of the treatment.
The primary goal is to measure the annual rate of moderate and severe exacerbations, while secondary goals include changes in symptom scores and lung function.
Who Can Join the Study?
Males and females aged 40 years or older who have given written permission to participate in the study.
Participants must be willing and able to learn how to use electronic devices for answering questions about their condition and performing necessary tests, like breathing tests.
Women can join the study if they cannot have children or, if they can have children, they must have a negative pregnancy test and agree to use birth control.
Participants must have a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis.
Current smokers or those who quit smoking at least 6 months before the study, 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.
Participants must have a specific lung function test result, showing less than 50% of the expected normal value after using a medicine that helps open the airways.
Participants must have had at least one moderate or severe worsening of their COPD in the past year, as confirmed by medical records.
Participants must have symptoms at the start of the study, shown by a CAT score of 10 or more. The CAT score is a questionnaire that measures the impact of COPD on a person’s life.
Participants must have been prescribed a combination of three types of COPD medicines (ICS, LABA, LAMA) for at least 12 months before the study and have been regularly using them for at least 3 months before the study starts. ICS must be in an approved dose for COPD.
Participants must be willing and able to learn how to use a specific type of inhaler called DPI inhalers (NEXThaler®).
Who Cannot Join the Study?
Patients who have a different lung condition other than Chronic Obstructive Pulmonary Disease (COPD).
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have a medical condition that might interfere with the study results or pose a risk to their health.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of substance abuse that might affect their ability to participate in the study.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who have a known allergy or sensitivity to the study medication or its ingredients.
Roflumilast: This medication is used to reduce inflammation in the lungs and is often prescribed for people with severe Chronic Obstructive Pulmonary Disease (COPD) to help prevent flare-ups. It works by decreasing swelling and irritation in the airways, making it easier to breathe.
Daliresp: This is a brand name for roflumilast, which is used to treat COPD. It helps to prevent the worsening of symptoms by reducing inflammation in the lungs.
CHF6001: This is an investigational medication being studied as an add-on treatment for COPD. It is being tested to see if it can further reduce the frequency of moderate and severe exacerbations when used alongside standard maintenance therapy. The goal is to improve breathing and reduce the number of flare-ups in patients with COPD and chronic bronchitis.
ICS, LABA, LAMA: These are types of medications commonly used in combination as maintenance therapy for COPD. ICS stands for inhaled corticosteroids, which help reduce inflammation in the airways. LABA stands for long-acting beta-agonists, which help relax the muscles around the airways to keep them open. LAMA stands for long-acting muscarinic antagonists, which also help to keep the airways open by blocking certain receptors in the lungs. These medications are often used together to help manage COPD symptoms and prevent exacerbations.
Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, which is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. The main symptoms include breathing difficulty, cough, mucus (sputum) production, and wheezing. People with COPD are at increased risk of developing heart disease, lung cancer, and a variety of other conditions. The disease progresses over time, leading to worsening symptoms and decreased lung function. Exacerbations, or episodes of worsening symptoms, are common and can be triggered by infections or environmental pollutants.
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