In the midst of the COVID-19 pandemic, breathing issues and respiratory conditions are significant concerns. According to the Centers for Disease Control and Prevention (CDC), people who have asthma are at increased risk of severe illness from COVID-19. The coronavirus could cause an asthma attack, ultimately leading to acute respiratory disease or pneumonia.
Asthma is a chronic disorder of the airways that is characterized by variable and recurring airway inflammation and bronchial hyperresponsiveness. Asthma is a condition that affects millions of people in all age groups. As many as 10% of people in the world have asthma, and up to 15% of the population may exhibit asthmatic conditions. While asthma can be as minor as an exercise-induced bronchospasm, it can also be life-threatening. More than 250,000 people die from asthma-related deaths every year. The pathophysiology of the condition can include airway inflammation as well as bronchial hyperresponsiveness and intermittent airflow obstruction. Severe asthma is a complex disease consisting of different endotypes with different inflammatory and clinical characteristics due to the heterogeneity of immune responses that can be classified into different endotypes.
Updated Asthma Guidelines from GINA
The Global Initiative for Asthma (GINA) was established in 1993 by the World Health Organization, the National Heart, Lung, and Blood Institute, and the National Institutes of Health. The GINA report "Global Strategy for Asthma Management and Prevention" has become a valuable resource for healthcare professionals around the world who seek the latest recommendations on how to manage asthma.
In 2019, the Global Initiative for Asthma (GINA) published new guidelines for managing and preventing asthma. The report introduces the most significant change in guidance on the treatment of the condition in three decades. Earlier guidelines treat asthma as a condition that involves bronchoconstriction, but current guidance emphasizes the airway inflammation that is often present in asthma patients.
Here are some of the most important takeaways from the new guidance.
What Are the Major Changes in the Updated Guidance?
One of the most significant changes from the updated GINA guidance is the way asthma is treated. Using short-acting beta2-agonists (SABA) alone is no longer recommended. While SABA-only treatment can provide short-term relief, it does not protect asthma patients from more severe complications. Further, regular use of SABAs can lower lung function. Instead, GINA recommends that both adults and adolescents be treated with controller treatments containing inhaled corticosteroids (ICS).
Treatments containing ICSs should be provided immediately after the asthma diagnosis to help prevent exacerbations and encourage better lung function. Ultimately, early ICS treatment reduces the risk of hospitalization and even death. Most asthma patients will only need a low dose of ICS. In the case of mild asthma, GINA recommends that patients receive the lowest dose ICS possible to control their symptoms as well as a low dosage of Formoterol. If the latter is not available, SABAs can be given, but they should only be taken in conjunction with a low-dose ICS.
Furthermore, asthma medications and their dosages should be regularly evaluated. As the frequency and severity of asthma symptoms change and respond to the treatments provided, those medicines should be deleted, or additional medication be added to the patient’s treatment.
Another important aspect is the understanding of the severe asthma. Historically, severe asthma has been referred to as severe refractory asthma, asthma emergency, asthma attack, or status asthmaticus. Under current guidelines—and with the introduction of biological therapies—these terms are incorrect, inaccurate, or lacking in specificity. Severe asthma is not markedly improved by addressing contributory factors of difficult-to-treat asthma such as inhaler technique and adherence issues. As detailed in the GINA report, severe asthma is a distinct type of difficult-to-treat asthma that remains uncontrolled with adherence to optimized therapy and treatment of contributory factors such as inhaler technique. If severe asthma persists despite optimization, the fourth step is to assess the specific severe-asthma phenotype: allergic versus eosinophilic. Patients with severe asthma also have worsening of symptoms when high-dose treatment is decreased.
Assessment of the patient's inflammatory phenotype is recommended once a patient is diagnosed with severe asthma and referred to a specialist for treatment. According to the GINA report, determining if the patient has type 2 or non–type 2 severe asthma can help optimize treatment choice with a targeted therapy.
How Will It Change the Dynamics of Sponsor Studies?
The new treatment guidelines mean that Sponsors will need to adjust their research programs accordingly. SABA alone is no longer the standard of care, so it cannot be used as a comparator in clinical research studies. In fact, several studies had to be withdrawn and terminated because of this change. It also means that these dramatic changes were possible due to the extensive research programs and lots of studies with SABA, which didn’t demonstrate anticipated efficacy.
How Have Things Changed from the Researcher Perspective?
Doctors worldwide should have been adjusted and adjusted the treatment of the patients. It is essential to be conversant with contemporary pharmacotherapy for asthma, especially for severe asthma. It also means that the new studies are in high need to prove new strategy treatment, especially long-term efficacy. For the severe asthma there is an unmet clinical need to develop and to validate biomarkers than can differentiate between asthma endotypes and guide clinical management. Biological therapies that target the inflammatory pathways involving IgE should be developed further. At Pharm-Olam, we are waiting and ready for the new trials.
- Bateman ED, et al. (2008) Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J, 31(1):143-78. https://www.ncbi.nlm.nih.gov/pubmed/18166595
- Centers for Disease Control and Prevention (2020). Risk of Severe Illness from COVID-19: CDC. [https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/asthma.html]
- Global Initiative for Asthma (2019). Pocket Guide for Asthma Management and Prevention: GINA. https://ginasthma.org/wp-content/uploads/2019/04/GINA-2019-main-Pocket-Guide-wms.pdf
- Tarlo, SM et al. (2008). Diagnosis and management of work-related asthma: American College of Chest Physicians Consensus Statement. Oct;134(4):892. [https://www.ncbi.nlm.nih.gov/pubmed/18779187]