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Abstract representation of scientific innovation

Abstract representation of scientific innovation

Respiratory Clinical Trials & Studies

Clinical trials are an essential step in the development of new treatments for respiratory diseases. Clinical trials and studies are a collaborative effort between investigators, pharmaceutical companies and volunteers. Sanofi is committed to supporting investigator sponsored studies and externally sponsored collaboration.  

Why are Respiratory Clinical Trials Important?

More than 545 million people across the globe (7.4% of the world’s population) are currently living with a chronic respiratory condition.1  

A chronic respiratory disease is any long-term condition that affects the lungs and the airways, for example, asthma and COPD.2 Respiratory conditions are caused by a complex interplay of genetics, the immune system and lifestyle, with different patients often responding to different treatments.3 

Clinical research aims to understand the mechanism by which these conditions occur to discover new modes of treatment. For instance, one of the key avenues in current respiratory disease research is the study of inflammatory biomarkers.4 

Respiratory clinical trials are important when we consider the scale and impact of these conditions: 

  • 300 million adults worldwide are affected by asthma.5 
  • More than 212 million reported cases of COPD.6 
  • Nasal polyps affect as much as 4% of the world population.7  
  • RSV causes over 3.6 million hospitalizations every year.8 
  • Influenza (flu) season has led to at least 47 million illnesses and 610,000 hospitalizations in 2025.9 
  • 197 million pneumonia episodes worldwide occurred in 2016 due to pneumococcal disease.10 

Sanofi’s Commitment to Respiratory Clinical Research

Sanofi recognizes the unmet needs and challenges for respiratory patients worldwide.  

For respiratory conditions like COPD, patients not responding to available treatments is a common occurrence.11 At Sanofi we have accelerated research and development to understand the different pathways involved in inflammation, and are leveraging artificial intelligence and data analysis platforms to research new treatment options.  

Read our Every Breath Matters blog to learn more about Sanofi’s respiratory research.

How are Patients Recruited for Respiratory Clinical Trials?

Recruitment for respiratory clinical trials is a multistep rigorous process. Volunteers typically learn about clinical trials by suggestion from their healthcare provider or independent research from public sources, like the US Clinical Trials Registry.  

Once a volunteer expresses their interest to participate in a clinical trial, they are provided with a patient information sheet and an informed consent form. A member of the medical staff conducting the trials will explain the objectives of the clinical trial, the process and any potential risks.  

Not every volunteer interested in a clinical trial may be eligible for the study. Each clinical trial has specific inclusion criteria for participants based on factors like medical history, severity of condition, previous treatments used and more. When the prospective participant has signed the informed consent form, they undergo a process called clinical trial screening. The screening process involves a recommendation from a healthcare provider, medical history review, physical exams and diagnostic tests relevant to the clinical trial.  

If the volunteer is found to be eligible based on the screening results, they can move on to participating in the trial. All participants in a clinical trial are volunteers, and can withdraw at any point for any reason. Learn more about the clinical trial recruitment process at Sanofi:

Importance of Inclusivity and Diversity in Respiratory Clinical Trials

Respiratory diseases manifest differently in different people. Diseases like asthma are known to be heterogenous, which means there are many different forms or ‘phenotypes’ of the condition.4 People with different genetic and immunological profiles may respond very differently to the same treatment.3 As such, there is no ‘one solution fits all’ in respiratory medicine. Our goal with respiratory clinical trials is to ensure every patient has access to treatment options specifically tailored to them.  

View our blog post on unmet needs in respiratory care.

With this in mind, respiratory clinical trials should ideally represent the diverse patient demographics that will use the treatment, to ensure that the therapy is safe and effective for all. Sanofi is committed to diversity in clinical trials and works to minimize barriers for historically underrepresented groups to participate in them:

Explore Sanofi's Respiratory Clinical Trials and Studies

We conduct respiratory clinical trials for vaccines and other therapeutics in an ever-expanding array of disease areas:

Asthma

COPD

Influenza and COVID-19

Pneumococcal disease

Nasal polyps

References

  1. GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020;8(6):585-596. doi:10.1016/S2213-2600(20)30105-3
  2. WHO. Chronic respiratory diseases. Accessed May 14, 2025. https://www.who.int/health-topics/chronic-respiratory-diseases#tab=tab_1
  3. Chang C. Unmet needs in respiratory diseases : “You can’t know where you are going until you know where you have been”. Clin Rev Allergy Immunol. 2013;45(3):303-313. doi:10.1007/s12016-013-8399-2
  4. Ma H, Yang L, Liu L, et al. Using inflammatory index to distinguish asthma, asthma-COPD overlap and COPD: A retrospective observational study. Front Med. 2022;9:1045503. doi:10.3389/fmed.2022.1045503
  5. Cukic V, Lovre V, Dragisic D, Ustamujic A. Asthma and chronic obstructive pulmonary disease (Copd) – differences and similarities. Mater Sociomed. 2012;24(2):100-105. doi:10.5455/msm.2012.24.100-1052022;35(6):737-745. doi:10.1080/08998280.2022.2096370
  6. Safiri S, Carson-Chahhoud K, Noori M, et al. Burden of chronic obstructive pulmonary disease and its attributable risk factors in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019. BMJ. 2022;378:e069679. doi:10.1136/bmj-2021-069679
  7. Newton JR, Ah-See KW. A review of nasal polyposis. Ther Clin Risk Manag. 2008;4(2):507-512. doi:10.2147/tcrm.s2379
  8. WHO. Respiratory syncytial virus (RSV). Accessed June 6, 2025. https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus-(rsv)
  9. CDC. Weekly us influenza surveillance report: key updates for week 17, ending april 26, 2025. FluView. May 9, 2025. Accessed July 1, 2025. https://www.cdc.gov/fluview/surveillance/2025-week-17.html
  10. Ramos B, Vadlamudi NK, Han C, Sadarangani M. Future immunisation strategies to prevent Streptococcus pneumoniae infections in children and adults. The Lancet Infectious Diseases. 2025;25(6):e330-e344. doi:10.1016/S1473-3099(24)00740-0
  11. Waeijen-Smit K, Houben-Wilke S, DiGiandomenico A, Gehrmann U, Franssen FME. Unmet needs in the management of exacerbations of chronic obstructive pulmonary disease. Intern Emerg Med. 2021;16(3):559-569. doi:10.1007/s11739-020-02612-9
MAT-GLB-2503230 - 1.0 - 08/2025