Asthma Clinical Trials & Studies
What are Asthma Clinical Trials and Studies?
Asthma clinical trials are research studies designed to evaluate the safety and effectiveness of new and innovative asthma treatment options.
Clinical research is a collaborative effort, bringing together investigators, pharmaceutical companies, and patients to advance medical knowledge and improve future care. Sanofi is committed to supporting investigator sponsored studies and externally sponsored collaborations.
Why are Asthma Clinical Trials Important?
Asthma is a chronic respiratory disease with complex underlying mechanisms and triggers that vary greatly between individuals.1 Nearly one in twelve American adults, approximately 28 million people, including 4.9 million children, have been diagnosed with asthma in the U.S.2 This condition carries a serious health burden, with over 3,500 deaths annually due to asthma-related complications.3
Despite advancements in treatment, researchers are still investigating the precise immune responses that drive disease severity and exacerbations.4
This is why clinical trials are essential for transforming these evolving immunological insights into new and more effective therapies that improve patient outcomes and help prevent severe asthma attacks.
Considering Patient Diversity in Asthma
Asthma doesn’t affect everyone the same way. Its severity and symptoms can vary depending on a person’s age, sex, or ethnicity. For example, asthma is more common in young boys, but after puberty, women are more likely to have it. Also, Black and Hispanic children are more likely to experience asthma and face more serious health effects from it compared to other groups.5
That’s why it’s important for asthma medical research to include people from all backgrounds to make sure new treatments work well and are safe for everyone. Learn why diversity and inclusivity is important in a clinical trial and why people volunteer for clinical trials.
Unmet Needs in Asthma Treatment
Even though there are several treatment options for asthma, like oral corticosteroids (OCS), many people with asthma still struggle to keep their symptoms under control.6
Additionally, when OCS are used in high doses over a long time, especially in children, they may cause side effects like slowed growth and changes in hormone levels.6
That’s why researchers are developing new medicines called biologics, which are a precision medicine designed to target the specific immune pathways that cause inflammation in asthma.6
Sanofi’s Commitment to Asthma Clinical Research
Sanofi is committed to advancing care for people living with asthma, particularly those with moderate-to-severe disease who remain inadequately controlled despite current treatments. Recognizing the diversity in asthma types, including eosinophilic inflammation and corticosteroid-dependent forms, Sanofi continues to invest in research aimed at addressing unmet needs in this space.7
One milestone includes the FDA approval of a biologic therapy for patients aged 12 years and older with specific forms of moderate-to-severe asthma on October 19, 2018. This approval was supported by three large Phase III trials, which enrolled over 2,800 participants globally.8
Types of Asthma Clinical Research Studies
Researchers are exploring multiple approaches to improve asthma care, not only through treatment, but also by enhancing the overall patient experience, from diagnosis to ongoing management.
- Treatment trials: compare new asthma medications or existing ones to each other or a placebo to find out which treatment works best for people with asthma.9
- Prevention studies: explore ways to reduce the chances of developing asthma before it begins. For example, the Childhood Asthma Prevention Study (CAPS).10
- Asthma biomarker studies: focus on understanding the biological changes and immune processes that drive asthma.11
- Equipment trials: test how safe and effective different asthma devices are, such as inhalers, nebulizers, or new technologies like breathing sensors.9
- Self-management programmes: these studies explore how patients manage their asthma in everyday life, using tools like diaries or questionnaires to track how well different self-care approaches work.9
Sanofi’s Asthma Clinical Trials
We have conducted various asthma clinical studies. Explore our current research studies on asthma:
References
- Causes and Triggers. NHLBI, NIH. Published April 17, 2024. https://www.nhlbi.nih.gov/health/asthma/causes
- Asthma Facts. Asthma & Allergy Foundation of America. Published April 23, 2025. https://aafa.org/asthma/asthma-facts/
- Facts and Stats - 8.3% of Americans Have Asthma. ACAAI Patient. Published February 13, 2024. https://acaai.org/asthma/asthma-101/facts-stats/
- Wang Y, Liu L. Immunological factors, important players in the development of asthma. BMC Immunology. 2024;25(1). doi:https://doi.org/10.1186/s12865-024-00644-w
- Trivedi M, Denton E. Asthma in Children and Adults—What Are the Differences and What Can They Tell us About Asthma? Frontiers in Pediatrics. 2019;7. doi:https://doi.org/10.3389/fped.2019.00256
- Caminati M, Vaia R, Furci F, Guarnieri G, Senna G. Uncontrolled Asthma: Unmet Needs in the Management of Patients. Journal of Asthma and Allergy. 2021;Volume 14:457-466. doi:https://doi.org/10.2147/jaa.s260604
- FDA Approves Asthma Indication for Dupixent® (dupilumab). Regeneron Pharmaceuticals Inc. Published 2018. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-asthma-indication-dupixentr-dupilumab
- Dupixent (dupilumab). Prescribing information.
- Asthma. Nihr.ac.uk. Published 2018. https://bepartofresearch.nihr.ac.uk/articles/asthma/
- Mihrshahi S, Peat JK, Webb K, et al. The Childhood Asthma Prevention Study (CAPS). Controlled Clinical Trials. 2001;22(3):333-354. doi:https://doi.org/10.1016/s0197-2456(01)00112-x
- Szefler SJ, Wenzel S, Brown R, et al. Asthma outcomes: Biomarkers. Journal of Allergy and Clinical Immunology. 2012;129(3):S9-S23. doi:https://doi.org/10.1016/j.jaci.2011.12.979