Asthma GINA Updates Fam Med Update 2021

4/16/21

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GINA 2020: Updates from the Global Initiatives

for AsthmaK E V I N F R A Z E R , M D

A S S O C I AT E P R O F E S S O R , FA M I LY A N D C O M M U N I T Y M E D I C I N E

U N I V E R S I T Y O F M I S S O U R I

FA M I LY M E D I C I N E U P D AT E 2 0 2 1

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LEARNING OBJECTIVES

1. Review the diagnostic criteria and evaluation of patients with asthma.

2. Provide updates to evidence-based clinical management based on the 2020 Global Initiative for Asthma (GINA) Report.

3. Review common medications used for acute and chronic management of asthma.

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Other famous GINAs:Not sure their thoughts on ICS-LABAs

GEENA DAVIS*Actress*Doesn’t cry playing baseball*Spells her name wrong, probably does not support GINA

GINA SILVEY*MU FCM residency coordinator*Local celebrity, surrogate mother to many residents *Doesn’t cry with making schedules

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ASTHMA GUIDELINE UPDATES

•GINA: Global Initiative for Asthma updated recommendations in 2019 and 2020

•NIH and National Heart, Lung, and Blood Institute updated recommendations in 2020

•Similarities and differences between the two organizations approaches/recommendations

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ASTHMA DEFINITION•“Heterogenous disease characterized by chronic airway inflammation”

•Defined by symptoms which vary over time and in intensity• Wheeze• Shortness of breath

• Chest tightness• Cough• Variable expiratory airflow limitations which may become persistent

•Symptoms often brought on by triggers and relieved by bronchodilator medications

•Bronchial hyperresponsiveness in reaction to stimuli

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ASTHMA PATHOPHYSIOLOGY•Airway biopsies show similar inflammatory process as with allergic response in nasal mucosa and skin• Supports belief of mast cell activation playing a role in asthma

• Eosinophil accumulation

•Airflow obstruction results from• Contraction of smooth muscle in airway

• Thickening of airway due to edema• Collection of mucus or cellular debris

• Airway remodeling

•Airway remodeling may lead to irreversible obstruction over time

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Current Asthma Prevalence: United States, 2001-2017

A b o u t 2 5 m illio n (8 % o f th e U .S . p o p u latio n ) h ad asth m a in 2 0 1 7 , an in cre ase fro m 2 0 m illio n , o r 7 .3 % w h o h ad asth m a in 2 0 0 1 .

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https://www.cdc.gov/asthma/Asthma_Prevalence_in_US.pptx

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Current Asthma Prevalence by Race and Ethnicity:United States, 2001-2017

B lacks are m o re like ly to h ave asth m a th an b o th w h ite s an d H isp an ics.

P e rce n t o f cu rre n t asth m a in cre ase d fo r w h ite s, b lacks, an d H isp an ics fro m 2 0 0 1 to 2 0 1 7 .


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Current Asthma Prevalence by Age Group, Sex, Race and Ethnicity, Poverty Status, Geographic Region, and Place of Residence:

United States, 2017

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A sth m a d id n o t d iffe r b y ag e g ro u p , re g io n , o r M e tro p o litan S tatistica l A re a (M S A ).


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Child and Adult Current Asthma Prevalence by Age and Sex: United States, 2017

M ale s an d fe m ale s ag e d 5 -2 4 ye ars h ad n o d iffe re n ce in p e rce n t o f cu rre n t asth m a.

A m o n g ch ild re n 0 -4 ye ars, m ale s h ad a h ig h e r p e rce n t o f asth m a an d am o n g ad u lts 2 5 ye ars an d o ld e r, w as h ig h e r fo r w o m e n th an m e n .

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Asthma Deaths: United States, 2001–2017

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T h e rate o f asth m a d e ath s d e c lin e d fro m 1 5 .0 p e r m illio n p o p u latio n in 2 0 0 1 to 1 1 .2 d e ath s p e r m illio n p o p u latio n in 2 0 0 8 . R ate s g rad u a lly p e ake d b e tw e e n 2 0 1 1 an d 2 0 1 4 b u t n o t s ig n ifican t.


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DIAGNOSIS•Evaluation focuses on use pulmonary function testing (PFTs)

•Consistent use of pulmonary function testing reduces risk of both UNDER-diagnosis and OVER-diagnosis

•May also consider:• CXR

• Allergy testing• Focused lab evaluation

• CBC

• Further based on evaluation of differential

Langan, AAFP, 2020

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DIAGNOSIS - PFTs•Office-based spirometry to measure FEV1 and FVC

• Determine baseline airflow obstruction (reduced FEV1/FVC)• Assess for reversibility of obstruction (albuterol response)

• Determine severity of obstruction• Evaluate for other causes of dyspnea – restrictive lung disease

•Full PFTs will also measure lung volumes and gas exchange• Can clarify if restrictive or mixed restrictive/obstructive

•Peak Flow device: monitor as opposed to diagnosis• Abnormal results can be suggestive but is not specific

• Peak flow responding to SABA supportiveLangan, AAFP, 2020

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Langan, AAFP, 2020

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Normal PFTs but still suspicious for asthma?

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ASTHMA - DIAGNOSIS•Consider bronchoprovocation testing if spirometry normal (normal ratio, no bronchodilator change)

Langan, AAFP, 2020

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ASTHMA - DIAGNOSIS

Also consider:

•Repeat spirometry at future visit when symptomatic

•Regular, routine home Peak Flow monitoring• Measure AM and PM, with and without symptoms, after bronchodilator

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ASTHMA – CLASSIFICATION (2020)

NAEPP Expert Report 3

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ASTHMA – TREATMENT GOALS•Reduce symptom burden

•Prevent exacerbations

•Maximize lung function

•Individualize treatment based on frequency and intensity of symptoms AND risk of exacerbations

•Education, communication and regular follow-up

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© Global Initiative for Asthma, www.ginasthma.org

n The GINA report is not a guideline, but an integrated evidence-based strategy focusing on translation into clinical practice

n Recommendations are framed, not as answers to isolated PICOT questions, but as part of an integrated strategy, in relation to:§ The GINA goals of preventing asthma deaths and exacerbations, as well as

improving symptom control§ Current understanding of underlying disease processes§ Human behavior (of health professionals and patients/carers)§ Implementation in clinical practice§ Global variation in populations, health systems and medication access

About the GINA strategy

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n Patients with apparently mild asthma are at risk of serious adverse events§ 30–37% of adults with acute asthma§ 16% of patients with near-fatal asthma§ 15–20% of adults dying of asthma

n Exacerbation triggers are variable (viruses, pollens, pollution, poor adherence)n Inhaled SABA has been first-line treatment for asthma for 50 years

§ This dates from an era when asthma was thought to be a disease of bronchoconstriction

§ Patient satisfaction with, and reliance on, SABA treatment is reinforced by its rapid relief of symptoms, its prominence in ED and hospital management of exacerbations, and low cost

§ Patients commonly believe that “My reliever gives me control over my asthma”, so they often don’t see the need for additional treatment

Background to changes in 2019 - the risks of ‘mild’ asthma

had symptoms less than weekly in previous 3 months (Dusser, Allergy 2007)

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Background to changes in 2019 - the risks of SABA-only treatment

n Regular or frequent use of SABA is associated with adverse effects§ b-receptor downregulation, decreased bronchoprotection, rebound hyperresponsiveness,

decreased bronchodilator response (Hancox, Respir Med 2000)

§ Increased allergic response, and increased eosinophilic airway inflammation(Aldridge, AJRCCM 2000)

n Higher use of SABA is associated with adverse clinical outcomes§ Dispensing of ≥3 canisters per year (average 1.7 puffs/day) is associated with higher risk of

emergency department presentations (Stanford, AAAI 2012)

§ Dispensing of ≥12 canisters per year is associated with higher risk of death (Suissa, AJRCCM 1994)

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n Since 2007, GINA has been actively seeking interventions for mild asthma§ to reduce the risk of asthma-related exacerbations and death§ to provide consistent messaging about the goals of asthma treatment, including prevention of

exacerbations, across the spectrum of asthma severity § to avoid establishing patient reliance on SABA early in the course of the disease

n GINA emphasized poor adherence as a modifiable risk factor for exacerbations § When the reliever is SABA, poor adherence with maintenance controller exposes the patient to

risks of SABA-only treatmentn GINA members repeatedly sought funding for RCTs of as-needed ICS-formoterol

for risk reduction in mild asthma§ Eventually culminated in 2014 with the initiation of the SYGMA studies, published in 2018

(O’Byrne NEJMed 2018; Bateman NEJMed 2018)

The 12-year history behind changes in GINA 2019

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n In the meantime, GINA challenged conventional criteria for initiation of ICS § During preparation for 2014 GINA revision, we identified no evidence for the

recommendation to withhold ICS until symptoms were more than twice weekly§ This was investigated in data from the START study (Pauwels, Lancet 2003). A post

hoc analysis found that ICS halved the risk of serious exacerbations even in patients with symptoms 0-1 days a week at entry (Reddel, Lancet 2017)

n GINA found no evidence to support a Step 1 SABA-only recommendation§ The lack of evidence for SABA-only treatment contrasted with the strong evidence for

safety, efficacy and effectiveness of treatments recommended in Steps 2-5§ In 2014, as an interim safety measure, GINA restricted SABA-only treatment to

patients with symptoms less than twice a month and no risk factors for exacerbations

n 2018: Review of evidence for mild asthma, including SYGMA studies§ A careful review of GINA conflict of interest processes was undertaken first

The 12-year history behind changes in GINA 2019

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GINA 2018 – main treatment figure

GINA 2018, Box 3-5 (2/8) (upper part)

Previously, no controller was recommended for Step 1, i.e. SABA-only

treatment was ‘preferred’

Step 1 treatment is for patients with symptoms <twice/month and no risk factors for exacerbations

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© Global Initiative for Asthma, www.ginasthma.orgGINA 2020, Box 3-5A

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2018 GINA

2019-2020 GINA

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n For safety, GINA no longer recommends SABA-only treatment for Step 1§ This decision was based on evidence that SABA-only treatment increases the risk of severe

exacerbations, and that adding any ICS significantly reduces the riskn GINA now recommends that all adults and adolescents with asthma should receive

ICS-containing controller treatment, to reduce the risk of serious exacerbations§ The ICS can be delivered by regular daily treatment or, in mild asthma, by as-needed low dose

ICS-formoterol

n This is a population-level risk reduction strategy§ Other examples: statins, anti-hypertensives§ Individual patients may not necessarily experience (or be aware of) short-term clinical benefit§ The aim is to reduce the probability of serious adverse outcomes at a population level

GINA 2019 – landmark changes in asthma management

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SYGMA 1: Symbicort Given as needed in Mild Asthma

•Double-blind RCT, 52 weeks enrolled patients aged 12 and older with clinical diagnosis of asthma for at least 6 months based on GINA criteria

•Enrolled 3849 patients, eligible if needing Step 2 treatment (uncontrolled with SABA PRN or well-controlled with ICS+SABA prn or LTRA+SABA prn)

•Compared• BID placebo + terbutaline (0.5mg) PRN• BID placebo + budesonide-formoterol (200 mcg budesonide with 6mcg formoterol) PRN • BID budesonide (200mcg) plus terbutaline PRN

•Sponsored by AstraZeneca

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•Primary outcome compared budesonide-formoterol PRN compared to prn terbutaline based on • Electronically recorded weeks with well-controlled asthma based on electronic-diary data for asthma

symptom scores, nighttime awakenings, morning peak flows, and use of inhaled/systemic steroids

•Secondary outcome compared budesonide-for PRN vs budesonide maintenance

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RESULTS•Primary outcome:

• Electronically recorded results with well-controlled asthma per patient• 34.4% in budesonide-formoterol PRN• 31.1% in Terbutaline PRN• OR 1.14 (1.00-1.30, p=0.046)

•Odds of having well-controlled asthma during the 52 weeks was 14% higher with PRN budesonide-formoterol

•Secondary outcome:• budesonide-formoterol PRN inferior to

budesonide maintenance therapy for weeks withwell-controlled asthma

◦ 34.4% vs 44.4%, OR 0.64 (0.57-0.73)

•Accumulative steroid dose lower in PRN budesonide-formoterol

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RESULTS

•Severe exacerbation: worsening asthma leading to use of systemic steroids ≥ 3 days, inpatient hospitalization or ED visit leading to use of systemic steroids

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•Double-blind RCT, 52 weeks in patients ≥12 years with mild asthma as defined by GINA criteria who were eligible for treatment with regular inhaled glucocorticoids

•Enrolled if needing Step 2 treatment (uncontrolled with SABA PRN or well-controlled with ICS+SABA prn or LRA+SABA prn)

•Assigned 4215 patients• Placebo BID maintenance with budesonide-formoterol (200 mcg budesonide with 6mcg formoterol) PRN• Budesonide BID 200mcg maintenance with terbutaline (0.5mg) PRN• 2-4 week run-in with only PRN terbutaline use

•Primary outcome: annualized rate of severe exacerbations

•Funded by Astra Zeneca

SYGMA 2: Symbicort Given as needed in Mild Asthma

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RESULTS

•Budesonide-formoterol PRN non-inferior to Budesonide maintenance with PRN terbutaline

•Rate of severe exacerbations: 0.11 vs 0.12

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RESULTS•Secondary Outcomes

• No difference in adherence• Higher total inhaled steroid dose in

maintenance arm• No difference in mean change of inhaler

reliever free days

• Change in baseline of FEV1 with bronchodilators was less in budesonide-formoterol PRN

• ACQ-5 score decreased less in budesonide-formoterol PRN

• No difference in adverse events

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ICS-formoterol is the preferred reliever for patients prescribed

maintenance and reliever therapy. For other

ICS-LABAs, the reliever is SABA

GINA 2020, Box 3-5A

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n Two additional RCTs of as-needed low dose budesonide-formoterol in mild asthma§ 12-month studies, open-label, no twice-daily placebo, i.e. the way it would be used in real life§ Novel START (Beasley et al, NEJM 2019, n=668) and PRACTICAL (Hardy et al, Lancet 2019,

independent study, n=885)

§ Significant reduction in severe exacerbations vs SABA alone, and vs maintenance ICS, with small or no difference in symptom control, and lower average ICS dose

§ Patients in RCTs of this regimen in mild asthma now total n=9,565n Both of these studies included inflammatory markers

§ FeNO was significantly reduced by as-needed ICS-formoterol (with average 3-5 doses per week) § Reduction in risk of severe exacerbations with as-needed ICS-formoterol was independent of

baseline characteristics, including blood eosinophils and exhaled nitric oxiden An additional RCT of taking ICS whenever SABA is taken (separate inhalers)

§ ASIST, in African-American children 6-17 years with mild asthma, compared with physician-adjusted treatment (Sumino et al, JACI in Pract 2019, n=206)

Additional supporting evidence

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•Open-label, 52 week, RCT in adults (aged 18-75) with mild asthma, self-reported diagnosis• Main inclusion criteria was use of SABA as sole asthma therapy in past 3 months who used it at least twice but on average of two or

fewer times/day in past 4 weeks

•Enrolled 675 patients

•Assigned to:• Albuterol PRN• Budesonide maintenance BID plus albuterol PRN• Budesonide-formoterol PRN

•Primary Outcome: annualized rate of asthma exacerbation defined as worsening asthma requiring urgent medical care visit, prescription for systemic steroids for any duration, episode of high beta agonist use (16 doses in 24 hours) or high ICS/LABA use (8 doses in 24 hours)

•Funded by Astra Zeneca

Novel START trial: Novel Symbicort TurbuhalerAsthma Reliever Therapy

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RESULTS•Primary outcome: exacerbation rate

• budesonide-formoterol PRN vs albuterol PRN: 0.195 vs 0.400, RR 0.49 (CI 0.33-0.72)

• budesonide-formoterol PRN vs budesonide maintenance: 0.195 vs 0.175, RR 1.12 (CI 0.7-1.79)

•Severe exacerbation: prescription of steroid for 3 days or hospitalization or ED visit requiring systemic steroids

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RESULTS•Enrollee at baseline:

• More women in budesonide groups• More severe exacerbations in past 12

months in albuterol only group

•Enrollees were less severe at baseline compared to SYGMA

•Authors note these findings support SYGMA 1 and 2 trials and ultimately support GINA 2019 updates

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•Open-label RCT, adults aged (18-75) with self-reported asthma diagnosis using SABA for symptom relief with or without maintenance low-moderate doses of inhaled steroids in past 12 weeks (mild-moderate asthma)• 55% female, average age 43, 79% European ethnicity

•Assigned 890 participants:• budesonide-formoterol (200mcg-6mcg) PRN• budesonide (200mcg) BID plus terbutaline (250mcg) PRN

•Primary outcome: number of severe exacerbations per patient per year defined as use of systemic steroids for at least 3 days or admission to hospital or ED visit requiring systemic steroids

•Funded by AstraZeneca

PRACTICAL trial: PeRsonalizedAsthma Combination Therapy with Inhaled Corticosteroid And fast-onset Long-acting beta agonist

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RESULTS•Rate of asthma exacerbations budesonide-formoterol PRN vs budesonide maintenance

• 0.119 vs 0.172, RR 0.69 (CI 0.48-1.00, P=0.049)

•Small overall difference but supports use of less

regular steroid

•Enrolled patients with mild-moderate asthma

•Complements Novel-START study

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WHERE TO START WITH MEDICATION DOSING?

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© Global Initiative for Asthma, www.ginasthma.orgGINA 2020, Box 3-4B

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WHAT ABOUT YOUNGER CHILDREN?

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© Global Initiative for Asthma, www.ginasthma.orgGINA 2020, Box 3-5B

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© Global Initiative for Asthma, www.ginasthma.orgGINA 2020, Box 3-4C

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© Global Initiative for Asthma, www.ginasthma.orgGINA 2020, Box 3-4D

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Low, medium and high doses of different ICS

n NOT a table of equivalence§ Suggested total daily doses for ‘low’, ‘medium’ and ‘high’ dose treatment options§ Based on available studies (very few) and product information§ Does NOT imply potency equivalence

n Doses may be country-specific depending on local availability, regulatory labeling and clinical guidelines

n Clinical relevance§ Low dose ICS provides most of the clinical benefit of ICS for most patients with asthma§ However, ICS responsiveness varies between patients, so some patients may need medium

dose ICS if their asthma is uncontrolled despite good adherence and correct technique § High dose ICS (in combination with LABA or separately) is needed by very few patients

• Its long-term use is associated with an increased risk of local and systemic side-effects, which must be balanced against the potential benefits

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Low, medium and high ICS doses: adults/adolescents

GINA 2020, Box 3-6A

DPI: dry powder inhaler; HFA: hydrofluoroalkane propellant; pMDI: pressurized metered dose inhaler (non-CFC); * see product information

This is NOT a table of equivalence. These are suggested total daily doses for the ‘low’, ‘medium’ and ‘high’ dose treatment options with different ICS.

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Low, medium and high ICS doses: children 6-11 years

GINA 2020, Box 3-6B

DPI: dry powder inhaler; HFA: hydrofluoroalkane propellant; pMDI: pressurized metered dose inhaler (non-CFC); * see product information

This is NOT a table of equivalence. These are suggested total daily doses for the ‘low’, ‘medium’ and ‘high’ dose treatment options with different ICS.

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Low, medium and high ICS doses: children 5 years and younger

GINA 2020, Box 3-6B

BDP: beclometasone dipropionate; DPI: dry powder inhaler; HFA: hydrofluoroalkane propellant; pMDI: pressurized metered dose inhaler (non-CFC)

This is NOT a table of equivalence. These are suggested total daily doses for the ‘low’ dose treatment options with different ICS.

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n As-needed low dose budesonide-formoterol § Prescribed in maintenance and reliever therapy (Steps 3–5), or as-needed only (Steps 1–2),

or within an asthma action plan§ From product information, the maximum recommended total in one day is 72 mcg formoterol

(12 inhalations of budesonide-formoterol Turbuhaler 200/6 mcg)

n As-needed low dose beclometasone-formoterol § Prescribed in maintenance and reliever therapy (Steps 3–5), or within an asthma action plan§ From product information, the maximum recommended total in one day is 48 mcg formoterol

(6 inhalations of beclometasone-formoterol pMDI100/6 mcg)

As-needed ICS-formoterol – maximum daily dose?

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NEED FOR REASSESSMENT AND MONITOR OF INTERVENTIONS

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n FDA boxed warning in March 2020 about risk of serious neuropsychiatric events, including suicidality, with montelukast§ Includes suicidality in adults and adolescents§ Nightmares and behavioral problems in children

n Before prescribing montelukast, health professionals should consider its benefits and risks, and patients should be counselled about the risk of neuropsychiatric events

Adverse effects with montelukast

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GINA 2020 on Asthma and COPD Overlap

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n Also called ‘asthma-COPD overlap’ or ‘asthma+COPD’§ NOT a single disease, but a descriptive label for patients commonly seen in clinical practice

n Asthma and COPD are heterogeneous and overlapping conditions § The definitions of asthma and COPD are not mutually exclusive

§ Each includes several phenotypes that are likely to have different underlying mechanisms

§ There is increasing interest in the potential for precision treatment

n However, the labels ‘asthma’ and ‘COPD’ are still clinically important, as evidence supports safety-based differences in treatment recommendations§ Asthma: never treat with bronchodilators alone (risk of death, hospitalization, severe exacerbations)

§ COPD: start treatment with LABA and/or LAMA without ICS

§ Patients with diagnoses of both asthma and COPD are more likely to die or be hospitalized if treated with LABA vs ICS-LABA (Gershon et al, JAMA 2014; Kendzerska et al, Annals ATS 2019)

§ High dose ICS may be needed for severe asthma, but should not be used in COPD (risk of pneumonia)

n Chapter 5 has been rewritten for clinical utility, focusing on clinical recognition and safe initial treatment

Patients with features of asthma and COPD

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Patients with features of asthma and COPD

GINA 2020, Box 5-2

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NAEPP 2020 Guidelines

SMART (Single Maintenance and Reliever Therapy) for Step 3-4

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QUESTIONS?

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RESOURCES• Asthma Management Guidelines: A report from the national asthma education and prevention program coordinating committee expert panel

working group, NEP3 2020 Guidelines

• Bateman E, Reddel H, O’Byrne P et al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma. N Engl J Med 2018; 378: 1877-1887.

• Beasley R, Holliday M, Reddel HK et al. Controlled trial of budesonide-formoterol as needed for mild asthma. N Engl J Med 2019; 380: 2020-2030.

• CDC Asthma Surveillance Data. https://www.cdc.gov/asthma/asthmadata.htm

• Global Initiative for Asthma, 2019 Guidelines, www.ginasthma.org

• Global Initiative for Asthma, 2020 Guidelines, www.ginasthma.org

• Hardy J, Baggott C, Reddel HK et al. Budesonide-formoterol reliever therapy vs maintenance budesonide plus terbutaline reliever therapy in adults with mild to moderate asthma: the PRACTICAL study, an independent open-label randomised controlled trial. Lancet 2019; 394: 919-928.

• Langan R and Goodbred A. Office spirometry: indications and interpretation. Am Fam Physician 2020; 101:362-368

• O’Byrne P, FitzGerald J, Bateman E et al. Inhaled combined budesonide-bormoterol as needed in mild asthma. N Engl J Med 2018; 378: 1865-1876.

• Pollart S and Elward K. Overview of changes to asthma guidelines: diagnosis and screening. Am Fam Physician 2009; 79: 761-767.

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https://www.cdc.gov/asthma/asthmadata.htm

http://www.asthma.org/

http://www.ginasthma.org/

Asthma GINA Updates Fam Med Update 2021

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