Asthma Clinical Trials | Chiesi’s Research on Treating Chronic Lung Disease

About the Asthma

Asthma is a chronic lung disease affecting 262 million people of all ages worldwide¹.

It is caused by inflammation and muscle tightening around the airways, which makes it harder to breathe. Particularly in low- and middle-income countries, asthma is often underdiagnosed and undertreated, potentially leading to more serious injuries for those affected by this condition².

Furthermore, asthma is an “invisible” disease, in the sense that it is not visible from the outside, although it can limit or challenge a person’s movements, senses or activities⁷.

People with undertreated asthma can suffer sleep disturbance, daytime fatigue, and poor concentration. Asthma sufferers and their families may miss school and work, with a financial impact on the family and wider community. If symptoms are severe, people with asthma may need to receive emergency health care and they may be admitted to the hospital for treatment and monitoring. In the most severe cases, asthma can lead to death².

Therefore, it's crucial not to underestimate the common symptoms, which can include²:

A persistent cough, especially at night

Wheezing when exhaling and sometimes when inhaling

Shortness of breath or difficulty breathing, sometimes even when resting

Chest tightness, making it difficult to breathe deeply.

These symptoms can be mild or severe and can come and go over time. Although asthma can be a serious condition, it can be managed with the right treatment, to overcome the limitations imposed by the disease. Some people experience worse symptoms when they have a cold or during changes in the weather. Other triggers can include dust, smoke, fumes, grass and tree pollen, animal fur and feathers, strong soaps, and perfume. Symptoms can also be caused by other conditions. It is essential for people experiencing asthma symptoms to consult a specialized healthcare provider².

Anyone can develop asthma at any age⁵. People with allergies or those exposed to tobacco smoke are more likely to develop asthma. This includes secondhand smoke (exposure to someone else who is smoking) and thirdhand smoke (exposure to clothing or surfaces in places where someone has smoked)⁶. Statistics show that females tend to have asthma more frequently than males3. Lastly, asthma is more prevalent among African American individuals compared to other ethnic groups⁴.

The Asthma Zone System

The asthma zone system is a method used to help people manage their asthma by dividing their symptoms into different zones based on severity. There are three zones: green, yellow, and red.

Green Zone

This is the "good to go" zone. Your asthma is under control, and you can do your usual activities without any trouble.

Yellow Zone

This is the "caution" zone. Your asthma is acting up a bit, and you need to be careful. It's like a warning sign to pay attention to your symptoms.

Red Zone

This is the "danger" zone. Your asthma is severe, and you need help right away. It's like a stop sign telling you to act immediately.

By recognizing which zone they're in, individuals with asthma can take appropriate actions outlined in their asthma action plan to manage their symptoms effectively and prevent serious complications⁸.

The Main Risk Factors

What are the main risk factors associated with ASTHMA?⁹

Asthma is more likely if other family members also have asthma – particularly a close relative, such as a parent or sibling.

Asthma is more common in people who have other allergic conditions, such as eczema and rhinitis (hay fever).

Urbanization is associated with increased asthma prevalence, probably due to multiple lifestyle factors.

Events in early life affect the developing lungs and can increase the risk of asthma. These include low birth weight, prematurity, exposure to tobacco smoke and other air pollution sources, and viral respiratory infections.

Exposure to a range of environmental allergens and irritants is also thought to increase the risk of asthma, including indoor and outdoor air pollution, house dust mites, molds, and occupational exposure to chemicals, fumes, or dust.

Children and adults who are overweight or obese are at a greater risk of asthma.

References:

Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-22 https://www.who.int/news-room/fact-sheets/detail/asthma
National Center for Health Statistics. (2023). 2022 NHIS Child Summary Health Statistics. U.S. Department of Health and Human Services. https://data.cdc.gov/d/wxz7-ekz9
Asthma and African Americans. (2021). https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=15#
Asthma in Adults https://aafa.org/asthma/living-with-asthma/asthma-in-adults/ #:~:text=Many people think of asthma, reasons for missed workdays.
Thirdhand Tobacco Smoke: Emerging Evidence and Arguments for a Multidisciplinary Research Agenda https://ehp.niehs.nih.gov/doi/10.1289/ehp.1103500
An invisible disease: severe asthma is more than just “bad asthma” https://erj.ersjournals.com/content/50/3/1701109?ctkey=shareline
Asthma Action Plan https://acaai.org/wp content/uploads/2021/07/asthma_actplan.pdf
Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-22

CHIESI AND ASTHMA

Chiesi Farmaceutici is fully committed to the care and improvement of the quality of life of people suffering from respiratory diseases including asthma. In the search for continuous improvement in the health of patients, Chiesi Farmaceutici researches and develops new therapeutic solutions.

About TANGO Trial

TANGO is a clinical trial to study CHF6001 in adults (18 to 75 years old) with uncontrolled asthma. CHF6001 is being developed as an add-on to other asthma medications. The main goal of this trial is to see if CHF6001, when added to standard medications, can help reduce asthma attacks in adults with uncontrolled asthma.

This trial will support the research of asthma and potential treatments for asthma.

View HCP Study Info View Patient Study Info

About TRECOS Trial

The TRECOS trial will be investigating the environmental impacts of asthma medication propellants by testing the safety and efficacy of 2 types of inhalers (HFA-134a and HFA-152a) with the approved asthma medication, CHF5993. HFA-134a is a hydrofluorocarbon (HFC) propellant, currently a widely used asthma inhaler propellant, which negatively impacts air quality and contributes to rising greenhouse gas emissions. There are currently an estimated 5 million inhalers in the EU that use HFCs as the propellant.1 HFA-152a is a new propellant with significantly less global warming impact and is overall safer for the environment.

The study will seek to learn if inhalers using the HFA-152a propellant will be safe and effective in treating asthma, while reducing greenhouse gas emissions. The other goal is to learn about any medical issues the participants might have after taking CHF5993 with either the HFA-134a or HFA-152a propellant, thereby contributing to a more comprehensive evaluation of the medications’ clinical safety and environmental impact.