This clinical trial is focused on studying the effects of a medication called CHF6001 DPI on individuals with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis. The medication contains an active substance known as Tanimilast and is administered as an inhalation powder. 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 treatment for these conditions. The maintenance treatment typically includes a combination of medications known as ICS (inhaled corticosteroids), LABA (long-acting beta-agonists), and LAMA (long-acting muscarinic antagonists).
Participants in the study will be randomly assigned to receive either CHF6001 DPI or a placebo, which is a substance with no active medication. The study will last for 52 weeks, during which participants will continue their regular maintenance therapy while also using the study medication. The main goal is to see if CHF6001 DPI can reduce the number of moderate and severe flare-ups of COPD and Chronic Bronchitis compared to those who receive the placebo. Throughout the study, participants will be monitored for any changes in their condition and any side effects they may experience.
By the end of the study, researchers aim to gather information on how CHF6001 DPI affects the overall health and quality of life of individuals with COPD and Chronic Bronchitis. This includes looking at changes in symptoms, lung function, and the need for additional medication. The findings from this study could help improve treatment options for people living with these chronic respiratory conditions.
1joining the study
Upon joining the study, participants are required to provide written informed consent. This step ensures understanding and agreement to participate in the trial.
2initial assessment
Participants undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis, and ensuring a history of at least one moderate or severe COPD exacerbation in the previous year.
3medication training
Participants receive training on how to correctly use the DPI inhalers (NEXThaler®) and electronic devices for completing COPD questionnaires. This step is crucial for accurate data collection and medication administration.
4randomization and treatment
Participants are randomly assigned to receive either the study medication CHF6001 DPI or a placebo. The medication is administered as an inhalation powder, and participants continue their maintenance triple therapy, which includes inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), and long-acting muscarinic antagonists (LAMA).
5treatment duration
The treatment period lasts for 52 weeks. During this time, participants are monitored for any changes in their condition, including the rate of moderate and severe exacerbations.
6follow-up assessments
Throughout the study, participants undergo regular assessments to evaluate the efficacy and safety of the treatment. This includes measuring lung function and completing health questionnaires.
7completion of study
At the end of the 52-week period, participants complete a final assessment. This includes a review of any changes in symptoms and overall health status.
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 perform necessary tests, like breathing tests.
Females can join the study if they are not able to 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.
Participants can be current smokers or those who quit smoking at least 6 months before joining the study, with a history of smoking at least 10 pack years (a way to measure how much someone has smoked over time).
Participants must have a specific lung function test result showing less than 60% of the expected normal value and a ratio of less than 0.7 after using a medication called salbutamol or albuterol.
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 a COPD Assessment Test (CAT) score of 10 or higher, indicating they have symptoms.
Participants must have been prescribed a combination of three maintenance therapies (ICS, LABA, LAMA) for at least 12 months before joining the study and have been using them regularly for at least 3 months before the study starts.
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 history of severe allergic reactions to any of the study medications cannot participate.
Individuals with other significant lung diseases, apart from COPD and Chronic Bronchitis, are excluded.
Patients who have had a recent heart attack or stroke are not eligible.
People with uncontrolled high blood pressure cannot join the study.
Participants who have been diagnosed with cancer in the past five years are excluded.
Individuals with severe liver or kidney disease are not allowed to participate.
Patients who are currently pregnant or breastfeeding cannot take part in the study.
Anyone who is unable to follow the study procedures or attend regular visits is excluded.
Participants who are currently involved in another clinical trial are not eligible.
CHF6001 is an investigational medication being studied as an additional treatment for people with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis. It is used alongside a standard maintenance therapy to see if it can help reduce the frequency of moderate and severe flare-ups of the disease over a year. The goal is to determine if adding CHF6001 to the usual treatment can provide better control of symptoms and improve the quality of life for patients.
ICS stands for inhaled corticosteroids, which are medications used to reduce inflammation in the airways, making it easier to breathe. They are a part of the maintenance therapy for COPD and help prevent symptoms from getting worse.
LABA refers to long-acting beta-agonists, which are medications that help relax the muscles around the airways. This makes the airways wider and helps people with COPD breathe more easily. LABAs are used regularly to help control symptoms and prevent flare-ups.
LAMA stands for long-acting muscarinic antagonists, which are medications that help open up the airways by blocking certain receptors in the lungs. This helps to improve breathing and reduce symptoms in people with COPD. LAMAs are part of the maintenance therapy to help manage the condition over the long term.
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, leading to breathing difficulties. The disease progresses slowly and can cause symptoms such as coughing, wheezing, and shortness of breath. Over time, the airways and air sacs in the lungs lose their elasticity, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways produce more mucus than usual, which can clog them.
Chronic Bronchitis – This condition is a type of COPD characterized by inflammation of the bronchial tubes, which carry air to and from the lungs. It leads to a persistent cough that produces mucus, often accompanied by wheezing and shortness of breath. The disease progresses as the lining of the bronchial tubes becomes inflamed and thickened, which narrows the airways and makes it difficult to breathe. Over time, the constant irritation and inflammation can cause the airways to produce more mucus, further obstructing airflow. Chronic bronchitis is often caused by long-term exposure to irritants, such as tobacco smoke or air pollution.
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