Diagnosis And Management Of Difficult
GINA has added an important addition to the resources that we offer to assist practitioners treating patients with asthma. A new Pocket Guide, Diagnosis and Management of Difficult-to-treat and Severe Asthma in adolescent and adult patients is now available on the GINA website, and print copies may be ordered via the Contact Us form on the website. Embracing the issue of severe asthma was a critical goal for the GINA Board of Directors and Science Committee, as their mission remains focused on maximizing benefit for patients with asthma whilst minimizing healthcare provider burden.
- November 16, 2022For Immediate Release Chronic obstructive pulmonary disease is a preventable and treatable
- On World Lung Day, the Forum of International Respiratory Societies Calls for Action to
Implementation Of Asthma Management Strategies Into Health Systems
To improve asthma care and patient outcomes, evidence-based recommendations must be disseminated and implemented nationally and locally and integrated into health systems and clinical practice . Implementation requires an evidence-based strategy involving professional groups and stakeholders and considering local cultural and socioeconomic conditions. The cost-effectiveness of implementation programs should be assessed so a decision can be made to pursue or modify them. Local adaptation and implementation of asthma care strategies are aided by purpose-developed tools .
Xolair Dosing Tool For Allergic Asthma
To determine how much XOLAIR to administer in a dose, enter the patients weight , pretreatment serum IgE level, and age.
Dosing Tool is intended for US healthcare professionals only.
For patients aged 6 to < 12 years whose pretreatment serum total IgE level or body weight is outside the limits of the dosing table , there is insufficient data to recommend a dose.1
For patients aged 12 years whose pretreatment serum total IgE level or body weight is outside the limits of the dosing table , there is insufficient data to recommend a dose.1
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S 1 And 2 Alternative Treatment
The alternative Step 2 recommendation for adults and adolescents remains regular, low-dose ICS with as-needed SABA. The Step 1 recommendation is taking ICS whenever SABA is taken .
Rationale
For patients with initial symptoms twice per month or more, low-dose maintenance ICS reduces the risk of serious exacerbations by almost half compared with SABA alone . There is a paucity of evidence for the safety and effectiveness of as-needed concomitant ICS + SABA, as only small groups received this regimen in studies of adults and children 518years . However, concomitant ICS + SABA would be preferable to using SABA alone if ICSformoterol is not available or affordable. No data are available about the acceptability to adults of carrying separate ICS and SABA inhalers for symptom relief or on what proportion of patients would revert to SABA-only use. No data are available about safe levels of as-needed ICS + SABA use, but in one study, exacerbations were higher among patients randomized to twice-daily ICSSABA than among those on as-needed ICSSABA , consistent with risks associated with SABA overuse .
S 1 And 2 Preferred Treatment
The preferred treatment for adults and adolescents with mild asthma is low-dose ICSformoterol taken as needed for symptom relief, without maintenance treatment . As-needed-only ICSformoterol is usually prescribed with a budesonideformoterol inhaler providing a metered dose of 200/6g per inhalation , with one inhalation taken as needed for symptom relief . Other combination ICSformoterol products may be suitable but have not yet been studied.
Rationale
In Step 1, the recommendation for as-needed, low-dose ICSformoterol for adults and adolescents with symptoms less than twice per month is supported by indirect evidence for a large reduction in the risk of severe exacerbations, compared with as-needed SABA alone . Extension of this recommendation to Step 1 was also supported by several important considerations:
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The Previous Gina Recommendation For Intermittent And Mild Asthma Management
Despite obvious evidence of airway inflammation in patients with mild asthma, SABA held a strong position in the GINA recommendations from 1995 until 2019 . The only changes over the years concerned the recommended maximum number of SABA inhalations during the first step of treatment, which varied from 1 inhalation per week in 1995 to 2 inhalations per week in 2006 and fewer than 2 inhalation per month in 2014. In 2002, formoterol, a long-acting 2-agonist with a rapid onset of action was recommended as a rescue medication but only in patients receiving ICS. The question then arises: Why was SABA not also considered as a rescue medication for use only in patients using ICS? In 2014, a fixed combination of ICS with formoterol was recommended as a rescue medication from the third step of treatment in patients receiving such medications as a maintenance therapy but not during the first or second steps, where a SABA was the only preferred rescue medication .
Fig. 4
Timeline for SABA position changes in asthma management according to the GINA guidelines 19952019 . ICS inhaled corticosteroids, LABA long acting beta2 agonist, RABA rapid acting beta2 agonist, SABA short acting beta2 agonist, SMART single inhaler maintenance and rescue therapy, maintenance and rescue therapy, BUD budesonide, BDP beclomethasone, FORM formoterol
It was a sign that there was a need for further changes in recommendations.
Special Articleglobal Initiative For Asthma Strategy : Executive Summary And Rationale For Key Changes
The Global Initiative for Asthma Strategy Report provides clinicians with an annually updated evidence-based strategy for asthma management and prevention, which can be adapted for local circumstances . This article summarizes key recommendations from GINA 2021, and the evidence underpinning recent changes.
GINA recommends that and adolescents should not be treated solely with short-acting 2-agonist , because of the risks of SABA-only treatment and SABA overuse, and evidence for benefit of inhaled corticosteroids . Large trials show that as-needed combination ICSformoterol reduces severe exacerbations by 60% in mild asthma compared with SABA alone, with similar exacerbation, symptom, lung function, and inflammatory outcomes as daily ICS plus as-needed SABA.
Key changes in GINA 2021 include division of the treatment figure for adults and adolescents into two tracks. Track 1 has low-dose ICSformoterol as the reliever at all steps: as needed only in Steps 12 , and with daily maintenance ICSformoterol in Steps 35. Track 2 has as-needed SABA across all steps, plus regular ICS or ICSlong-acting 2-agonist . For adults with moderate-to-severe asthma, GINA makes additional recommendations in Step 5 for add-on long-acting and , with add-on biologic therapies for . For children 611 years, new treatment options are added at Steps 34.
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Japanese Society Of Allergology
Guidelines for adult asthma were published in October 2020 by the Japanese Society of Allergology .
Diagnosis
The JSA recommends spirometry for assessing the extent of airflow limitation or airway reversibility.
The JSA recommends daily measurement of peak expiratory flow for unstable asthma and patients lacking obvious dyspnea during attack.
Although useful for diagnosing asthma, the JSA does not recommend assessing bronchial hyperresponsiveness in patients with low FEV1 or low %FEV1 since excess airway narrowing may occur due to irritant inhalation.
Treatment of long-term adult asthma
The JSA recommends using a jet nebulizer for budesonide inhalation suspension.
The JSA recommends adding one or more agents other than inhaled corticosteroids , as opposed to increasing the dose of an ICS, to control asthma.
The JSA recommends long-acting 2-agonists , leukotriene receptor antagonists , sustained-release theophylline, and long-acting muscarinic antagonists as add-on drugs.
The JSA recommends that anti-immunoglobulin E antibodies and other biologics as well as oral steroids be reserved for very severe and persistent asthma related to allergic reactions.
The JSA recommends inhaled 2-agonists, aminophylline, corticosteroids, adrenaline, oxygen therapy, and other approaches be used as needed during acute exacerbations.
Treatment during pregnancy
The JSA recommends ICSs as first-line treatment for long-term management of pregnant women with asthma.
Global Initiative For Asthma
ABOUT GINA
We work with health care professionals, patient representatives, and public health officials around the world to reduce asthma prevalence, morbidity, and mortality.
It is important to understand that while GINA strives to be a globally relevant voice, recommendations for asthma care need to be adapted to local conditions, resources, and services. Talk with your healthcare provider about what is right for you.
Through resources such as evidence-based strategy documents for asthma management, and events such as the annual celebration of World Asthma Day, GINA is working to improve the lives of people with asthma in every corner of the globe.
GUIDELINES & REPORTS
The GINA global strategy for asthma management and prevention is presented in its strategy documents, which are freely available on the GINA Website.
The GINA Scientific Committee prepares updates to these documents each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the worlds literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.
PATIENT RESOURCES
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General Principles Of Asthma Management
The goals of asthma management are to achieve good symptom control, relieve symptoms when they occur, and minimize the risk of exacerbations and asthma-related death, persistent airflow limitation, and side effects of treatment. The patient’s own treatment goals should be identified because they may be different. Effective asthma management requires a partnership between the patient and healthcare providers, with shared decision-making and good communication.
Asthma management is not one-size-fits-all but instead should be personalized and adjusted in a continual cycle of assessment, treatment adjustment, and review .
Personalized asthma management cycle of care. Reproduced by permission from reference 4 .
Asthma Management During The Covid
Most studies have shown that patients with asthma are not at increased risk of acquiring coronavirus disease 2019 or of severe COVID-19. Advise patients to continue taking their prescribed asthma medicines, including inhaled corticosteroids , alone or in combination with a long-acting 2-agonist , and biological therapy for severe asthma.
Avoid the use of nebulizers, where possible, because of the risk of viral transmission. Within healthcare facilities, follow local infection control procedures and COVID-19 testing recommendations if spirometry, peak expiratory flow measurement, or other aerosol-generating procedures are needed.
GINA recommends COVID-19 vaccination for people with asthma, with usual precautions including checking for allergies to vaccine ingredients. Anaphylaxis to foods, insect venom, or medications is not a contraindication. Consider giving the first dose of asthma biologic therapy on a different day from the COVID-19 vaccine.
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Managing Exacerbations At Home
Give a written asthma action plan to parents/caregivers of young children with asthma so they can recognise an impending exacerbation, start treatment, and identify when urgent hospital treatment is required. Initial treatment at home is with inhaled SABA, with review after 1h or earlier. If inhaled SABA is needed more often than every 3h or for > 24h, treatment by a health provider is needed on the same day. Parents/caregivers should seek urgent medical care if the child is acutely distressed, lethargic, fails to respond to initial bronchodilator therapy, or is worsening, especially in children younger than 1year.
Rationale
Most children with wheezing due to asthma respond to SABA. There is insufficient evidence for parent-initiated OCS in this age group. Pre-emptive, episodic, parent-initiated high-dose nebulized ICS may reduce exacerbations in children with intermittent virally triggered wheezing , but there are no long-term studies, and there is a high risk of side effects it should only be considered if the clinician is confident that it will be used appropriately and that the child will be monitored closely for side effects.
Clinical Evidence From First Short Term Studies Supporting The Bud
In 2006, two very interesting studies on the use of BUD-FORM as a rescue medication were published. In Bateman et al. study, budesonide-formoterol and formoterol provided similarly rapid relief of acute bronchoconstriction in patients with asthma who were previously refractory to SABA treatment. The second study was SOMA, performed by Haahtela et al. The investigators compared the as-needed use of RABA with the as-needed use of a RABA and corticosteroid fixed combination as the only medication in asthma patients with intermittent symptoms. The study population consisted of patients who had previously only used RABA as needed with FeNO> 20 ppb. Baseline FeNO was 60 ppb and 59 ppb in the BUD-FORM and formoterol groups, respectively. During the 24 weeks of the study, FeNO was significantly reduced in patients receiving a combination of drugs from the fourth week of therapy until the end. The number of days of rescue medication use was significantly lower in the BUD-FORM group compared to the FORM group . The authors concluded that the as-needed use of ICS-RABA may be more beneficial than using RABA alone in patients with intermittent asthma and signs of airway inflammation.
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Limitations Of 2020 Focused Updates
The expert panel kept its focus on asthma. The immunotherapy recommendations apply only to their role in asthma and not other elements of allergy care. The updates do not address biologics because the evidence for biologics was limited when topics were selected. Cost of care was acknowledged, but it was out of scope to address the complex nature of health care payment and insurance coverage. The updates did note the potential impact on disparities for recommended tests and treatments within each topic area.
These Focused Updates are an important resource for navigating the increasingly complex care options for asthma. The expert panel invites feedback from family physicians on these recommendations and other areas where significant clinical questions persist .
Ping Down To Find The Minimum Effective Dose
When good asthma control has been achieved and maintained for 23months, consider stepping down to find the lowest effective step. Do not completely withdraw ICS, except if needed temporarily while confirming the diagnosis of asthma. Adults and adolescents with well-controlled asthma while on daily low-dose controller therapy can step down to either as-needed ICSformoterol or to as-needed ICS + SABA taken together .
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Primary Prevention Of Asthma In Children
The development and persistence of asthma are driven by geneenvironment interactions. For children, a window of opportunity to prevent asthma exists in utero and in early life, but intervention studies are limited. Current advice and recommendations for preventing asthma in children, based on high-quality evidence or consensus, include the following:
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Avoid exposure to environmental tobacco smoke during pregnancy and after birth.
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Encourage vaginal delivery where possible.
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Where possible, avoid the use of acetaminophen and broad-spectrum antibiotics during the first year of life.
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Identification and correction of vitamin D insufficiency in women with asthma who are pregnant, or planning pregnancy, may reduce the risk of early-life wheezing episodes, but not asthma.
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Allergen avoidance strategies directed at a single allergen have not been effective in preventing asthma. Multifaceted strategies may be effective, but the essential components have not been identified.
Breast-feeding is advised for its general health benefits.
Diagnosis And Initial Treatment Of Patients With Features Of Both Asthma And Chronic Obstructive Pulmonary Disease
Asthma and chronic obstructive pulmonary disease are umbrella labels for overlapping heterogeneous conditions. Symptoms may be similar, and the diagnostic criteria overlap. Some patients have features of both asthma and COPD , particularly smokers and older adults. This is not a single disease entity. It includes several clinical phenotypes that are likely caused by a range of underlying mechanisms.
There are important differences in evidence-based treatment recommendations
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Epidemiological Data And Clinical Studies On Excessive Use Of Saba
The use of adrenoceptor agonists dates back to 3000 BC when Chinese medicine practitioners used ma huang extracts containing ephedrine in the treatment of respiratory symptoms . At the beginning of twentieth century, the nonselective -AR and ß-AR agonist epinephrine was introduced into clinical practice and administered by the subcutaneous route for the treatment of acute asthma . Although highly efficacious, epinephrine caused serious adverse event due to its effect on and ß -ARs in the cardiovascular system. Isoprenaline and metaproterenol were next AR agonists interacting only with ß-AR but non-selective to their subtypes . Their administration was complicated by cardiac adverse events as they did not discriminate between ß1- and ß2-ARs ). The development of selective ß2-AR agonists salbutamol , terbutaline and fenoterol started the modern era of short acting ß2 agonists . These drugs were used by inhalation route thanks to the construction of the first personal inhalers in 1940s1950s . High efficiency in relieving acute bronchospasm resulted in the popularity of these drugs and their market increased rapidly all over the world, but quite early, there were doubts about their safety due to numerous side effects, especially serious affecting the circulatory and respiratory systems .
Fig. 1
Asthma Management In Low
GINA 2021 is a global strategy relevant to the care of all children, adolescents, and adults with asthma, wherever they live. Most of the global burden of asthma morbidity and mortality occurs in low-income and middle-income countries because of lack of necessary resources for effective long-term asthma care . GINA has identified ongoing lack of access to ICS as a serious concern , especially as they can be produced at low cost. The safest and most effective approach to asthma treatment in adolescents and adults, which also avoids the consequences of starting treatment with SABA alone, depends on access to ICSformoterol across all asthma severity levels . However, despite listing of budesonideformoterol on WHO’s Essential Medicines List , affordable access is very limited in many low-resource settings . The urgent need to ensure access to affordable, quality-assured inhaled asthma medications as part of universal health coverage must now be prioritized by all relevant stakeholders, particularly manufacturers of inhalers on the WHO Essential Medicines List .
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New Gina Recommendation For Mild Asthmatics
At the time the 2019 GINA Report was published, neither BUD-FORM nor BDP-FORM had been registered as on-demand relievers when not used in maintenance treatment nonetheless, the GINA experts issued this recommendation. For safety reasons, GINA no longer recommends using SABAs as monotherapy.
GINA experts recommend low-dose ICS-FORM as needed as the preferred treatment option during the first step of treatment for patients who suffer from asthma symptoms less than twice per month and who are not at risk of exacerbation. An alternative option is the use of low-dose ICS whenever SABA is taken. Maintenance use of low-dose ICS was recommended in 2014 for patients with risk factors, but this therapy is no longer recommended due to the low rate of compliance in these patients and the risk of exposing them to SABA-only treatment.
In addition to the other preferred options, low-dose ICS-FORM as needed and low-dose ICS and SABA as needed were added by experts to the list of potential options for the second step of treatment. The alternative options include low-dose ICS whenever SABA is taken as well as a leukotriene receptor antagonist.
What changes have caused these recommendations to appear?