Study on the Effectiveness and Safety of Tanimilast for Patients with Uncontrolled Asthma on Inhaled Corticosteroid and Long-Acting Beta2-Agonist Therapy
This clinical trial is focused on studying the effects of a new treatment for Asthma, a condition that affects the airways in the lungs, making it difficult to breathe. The treatment being tested is called CHF6001 DPI, which is an inhalation powder containing the active substance Tanimilast. This study will compare the effects of CHF6001 DPI to a placebo, which looks like the treatment but does not contain the active substance.
The purpose of the study is to evaluate how well CHF6001 DPI works in reducing asthma flare-ups when added to the usual asthma medications, which include medium or high doses of inhaled corticosteroids and long-acting beta2-agonists. Participants in the study will be randomly assigned to receive either CHF6001 DPI or a placebo, in addition to their regular asthma treatment, for a period of 52 weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo.
Throughout the study, participants will continue their regular asthma medications and will be monitored for any changes in their asthma symptoms. The main focus will be on the number of asthma exacerbations, or flare-ups, that occur during the study period. Additional observations will include the time it takes for the first asthma exacerbation to occur and any changes in asthma control and symptoms over time. The study aims to provide valuable information on the safety and effectiveness of CHF6001 DPI as an additional treatment option for people with uncontrolled asthma.
1randomization
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the CHF6001 DPI (tanimilast) inhalation powder, and the other group will receive a placebo. This process ensures that the study results are unbiased.
2medication administration
You will use the assigned inhalation powder daily. The total daily dose of CHF6001 is 3200 micrograms. This medication is an add-on to your current asthma treatment, which includes medium or high dose inhaled corticosteroids combined with long-acting beta2-agonists.
3treatment duration
The treatment will last for 52 weeks. During this period, you will continue to use your assigned inhalation powder daily as part of the study.
4monitoring and assessments
Throughout the study, your asthma condition will be monitored. This includes tracking the number of asthma exacerbations, which are episodes where your asthma symptoms worsen significantly.
You will also complete the Asthma Control Questionnaire (ACQ-7) at various points, specifically at Week 4, Week 26, and Week 52, to assess changes in your asthma control.
5lung function tests
Lung function tests will be conducted to measure changes in your breathing ability. These tests will occur at the start of the study and at regular intervals, including Week 4, Week 26, and Week 52.
6symptom tracking
You will use an electronic diary to record your asthma symptoms and any use of rescue medication. This information helps track your asthma control and the effectiveness of the treatment.
7end of study
At the end of the 52-week period, your participation in the study will conclude. Final assessments will be conducted to evaluate the overall impact of the treatment on your asthma.
Who Can Join the Study?
The patient must provide written permission to participate in the study before any study-related activities begin.
Women can join the study if they are not able to become pregnant, such as women who have gone through menopause (no periods for 12 months) or have been permanently sterilized. Women who can become pregnant must have a negative pregnancy test and agree to use reliable birth control methods during the study.
Men and women aged between 18 and 75 years can participate.
The patient must have a history of asthma diagnosed by a doctor for at least one year, with the diagnosis made before the age of 50.
The patient must have been on a stable asthma treatment with a combination of medium to high doses of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA) for at least three months before the study starts.
The patient must have a lung function test showing a Forced Expiratory Volume in the first second (FEV1) of 80% or less of the normal value, after stopping bronchodilators, at the screening and randomization visits.
The patient must show an improvement in lung function (more than 12% and more than 200 mL) in either FEV1 or Forced Vital Capacity (FVC) after inhaling a bronchodilator like salbutamol (albuterol).
The patient must have poorly controlled asthma, shown by a score of 1.5 or higher on the Asthma Control Questionnaire (ACQ-7) at screening and randomization.
The patient must have a history of asthma worsening, with at least one episode leading to hospitalization in the last 12 months, or two or more episodes in the last 12 months that required treatment with systemic corticosteroids (SCS), hospitalization, or an emergency room visit.
The patient must be willing and able to use inhalers correctly, perform all study-related tasks, including lung function tests, and use an electronic diary and home spirometer.
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 other significant lung diseases besides asthma.
Patients who have had a recent respiratory infection that required antibiotics or antiviral treatment.
Patients who are currently smoking or have a history of heavy smoking.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a history of alcohol or drug abuse.
Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
CHF6001 is a medication being tested in this trial. It is used as an additional treatment for people with asthma who are already taking medium to high doses of inhaled corticosteroids combined with long-acting beta2-agonists. The goal of adding CHF6001 is to see if it can help reduce the number of asthma attacks over a year.
Inhaled Corticosteroids are medications that help reduce inflammation in the airways, making it easier to breathe. They are commonly used as a long-term treatment to control asthma and prevent symptoms.
Long-acting Beta2-agonists are medications that help relax the muscles around the airways, making it easier to breathe. They are used in combination with inhaled corticosteroids to help control asthma symptoms over a longer period.
Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. These symptoms can vary in intensity and may worsen during physical activity or at night. Asthma is typically triggered by allergens, respiratory infections, cold air, or exercise. The condition can lead to episodes known as asthma attacks, where symptoms become more severe. Over time, asthma can cause changes in the airways, making them more sensitive and reactive to triggers.
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