2022 GINA guidelines regarding indications of regular controller treatment in children aged ≤5 years with asthma.


Asthma management in young children aims to achieve good symptom control, maintain normal activity levels, and reduce the risk of asthma exacerbations, impaired lung development, and drug side effects.

Global Initiative for Asthma (GINA) guidelines, 2022, regarding indications of regular controller treatment in children aged ≤5 years with asthma:

Intermittent or episodic wheezing of any severity can be caused by an isolated viral-induced wheezing episode, a seasonal or allergen-induced asthma, or unrecognised uncontrolled asthma. For all of these conditions, wheezing is initially treated with a short-acting beta-2 agonist (SABA) every 4-6 hours as needed until symptoms resolve, usually within 1-7 days. However, there is uncertainty regarding the use of additional drugs in these children, especially when the nature of the episode is unclear. The indications of regular controller treatment in these children:

  • Regular controller treatment should be started, and the response should be assessed if the history and symptom pattern indicate an asthma, respiratory symptoms are uncontrolled, and/or wheezing episodes are frequent (e.g., ≥3 episodes in a season).
  • Regular controller treatment might be considered if a child presents with less frequent but more severe episodes of viral-induced wheezing.
  • A trial of regular controller treatment should be considered to determine whether the symptoms are caused by asthma if the diagnosis of asthma is uncertain, and inhaled SABA therapy or courses of antibiotics need to be repeated frequently, e.g. more than every 6-8 weeks. At this stage, the patient should be referred for specialist advice.

Natural Ways to Ease Asthma Symptoms


Beyond Medication

Beyond Medication

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If you have asthma, you know how important it is to take your medication as prescribed by your doctor. That often means using a long-term control drug every day and keeping a quick-relief inhaler handy. But managing asthma isn’t only about medication. You can do several other things to help you breathe as freely and easily as possible.

Grab an Espresso

Grab an Espresso

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While coughing, wheezing, and trouble breathing call for your rescue inhaler, you might consider a caffeinated drink if your symptoms are mild. Caffeine is a weak bronchodilator, which means it opens your airways a bit. More research is needed, but some studies suggest that it may help your lungs work better for up to 4 hours.

Hit the Steam Room

Hit the Steam Room

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Many people with asthma find warm air soothing. A steam bath — in a sauna or your shower at home — can help clear out mucus that can make it hard to breathe. One word of caution: Some people find that heat makes their asthma worse, so it’s important to know your personal triggers.

Add Spice to Your Life

Add Spice to Your Life

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Garlic and ginger have anti-inflammatory compounds that might ease your asthma symptoms. Start with fresh garlic cloves and ginger root. You can steep either one in boiling water and drink it like tea after the water has cooled, or just use these spices more often in your cooking.

Learn to Decompress

Learn to Decompress

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When you’re stressed, all the muscles in your body tense up, including the ones in your chest. Managing that tension may mean fewer asthma flare-ups. Meditation and yoga are good options, as is tai chi, an ancient, gentle Chinese martial art. Research suggests that it can help control asthma symptoms in some people.

Keep Moving

Keep Moving

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Exercise can make your lungs stronger, but it can also be an asthma trigger, especially if you’re out in cold weather. To stay safe, talk to your doctor before starting a new routine and ask if you should take medication before you get moving. Also be sure to work your way up slowly (think walking, then jogging, then running). And heed the weather: If it’s cold out, cover your mouth and nose or move your workout indoors.

Eat the Rainbow

Eat the Rainbow

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Colorful produce is rich in antioxidants like beta-carotene and vitamins C and E that help fight inflammation in your body, including in your lungs. And while you’re watching your diet, be careful with sulfites, a type of preservative that triggers asthma symptoms in some people. You’ll often find them in wine, dried fruit, pickles, and shrimp.

Let the Sun Shine

Let the Sun Shine

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Many Americans are low in vitamin D, and people with severe asthma might be more likely to have this issue. Ask your doctor to test your levels. If you don’t have enough, milk, eggs, and bony fish like canned salmon can help. Your body also makes vitamin D when you’re in sunlight. Just remember to use sunscreen, and don’t stay out too long or you could raise your chances of skin cancer.

Take Deep Breaths

Take Deep Breaths

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Special breathing exercises can help your lungs work better. Pursed lip breathing is one option: Breathe in through your nose, then breathe out at least twice as slowly through pursed lips. Diaphragmatic breathing, also called belly breathing, is another useful technique. If you need help with these, your doctor can refer you to a specialist.

Watch the Weather

Watch the Weather

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Cold or dry air may make your symptoms worse. When the mercury dips, you might drape a scarf around your mouth and nose to make it easier to breathe. Your indoor air matters, too. A dehumidifier or humidifier can help make sure your air isn’t too humid or too dry. And remember to keep windows closed and run the air conditioner during allergy season to keep pollen out.

Mind the Scale

Mind the Scale

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Extra fat around your chest and belly can make it harder to breathe, and fat cells can cause inflammation that may affect your airways. Cutting back on calories and fat and walking each day can help.

Know Your Triggers

Know Your Triggers

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Many people with asthma also have allergies, and common allergens like pollen, dust mites, and pet dander can make your asthma symptoms flare if you’re sensitive to them. If you haven’t recently been tested for allergies, see an allergist so you can find out exactly what bothers you and try stay away from it.

Therapy for Mild to Moderate Asthma


Guideline title Global Strategy for Asthma Management and Prevention (GINA Strategy Report)

Release date April 26, 2021

Prior version April 3, 2020

Developer and funding source The Global Initiative for Asthma (GINA)

Target population Patients aged ≥12 y with asthma

Major recommendations

  • Short-acting β-agonist (SABA) monotherapy is no longer recommended (level of evidence: A).
  • There is no distinction between mild-intermittent and mild-persistent asthma; inhaled corticosteroid (ICS)–containing therapies are recommended for both. ICS-formoterol is recommended as the preferred reliever inhaler (level of evidence: A).
  • For treatment of moderate asthma, GINA recommends ICS-formoterol maintenance and reliever therapy in the preferred track (level of evidence: A).

Summary of the Clinical Problem

Asthma is a disease characterized by recurring, reversible airways obstruction due to underlying inflammation and bronchial hyperresponsiveness. Asthma is one of the most common chronic noncommunicable diseases, affects an estimated 260 million people globally, and is associated with significant morbidity and mortality.1 Asthma with usually mild or infrequent symptoms (50%-75% of patients with asthma) contributes to 30% to 40% of exacerbations leading to emergency care; asthma-related death may occur in persons with asthma that is usually mild.2

Characteristics of the Guideline Source

GINA is a collaboration of the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI), and World Health Organization. The GINA Science Committee, composed of international leaders in asthma research and clinical practice, meets twice yearly to review new literature and assess its influence on management guidelines. Reviewers of published research must be neither an author nor have a declared conflict of interest (Table). GINA states that the guideline goes through extensive external review prior to publication. GINA assigns evidence ratings based on the NHLBI scale. Recommendations with evidence level A are based on data supported by multiple large randomized clinical trials (RCTs), systematic reviews, or observational studies in the target population. This guideline synopsis discusses 3 recommendations supported by level A evidence.

Evidence Base

In 2019, GINA altered its framework, recommending against the use of monotherapy with SABA. This change was motivated by evidence from retrospective studies that suggested increased use of SABA canisters, or use of SABA-only therapy, was associated with a higher risk of exacerbation and death. This risk is reduced with the addition of ICS. In a study from 2012, each additional SABA canister dispensed was associated with an 18% (OR, 1.18 [95% CI, 1.16-1.21]) increased risk of ED visit or hospitalization.3 Absolute reductions were not reported. On the other hand, in a case-control study from 2000, ICS use was associated with a decreased risk of death of 21% (adjusted rate ratio, 0.79 [95% CI, 0.65-0.97]) for every additional canister of ICS used.4

Most asthma guidelines, except that of the National Asthma Education and Prevention Program (NAEPP), now recommend some form of ICS as part of the treatment regimen (step 1-2) for mild asthma: either (1) ICS as needed whenever SABA is used, (2) scheduled twice-daily maintenance ICS and SABA as needed, or (3) the use of ICS-formoterol as needed. Formoterol, a long-acting β-agonist (LABA), is unique in that its rapid onset of action enables its use as an effective reliever medication. It has also been proven to be safe when used multiple times daily.

This GINA 2021 Strategy Report suggests 2 treatment tracks: “preferred track” and “alternative track.” In the preferred track, ICS-formoterol is the reliever of choice. SABA relievers, along with an ICS-containing inhaler, are used in the alternative track, where track 1 is not possible, or not preferred by a patient with no exacerbations while taking their current therapy. These recommendations are based on RCTs that demonstrated lower rates of exacerbation with preferred track therapy and lower overall use of ICS.57 In 2 representative studies, cumulative ICS dose in the as-needed ICS-formoterol groups was 17% to 24% of the dose in the maintenance to ICS groups, with a 60% to 64% reduction in exacerbations (absolute risk reduction [ARR], 22%) among those taking ICS-formoterol as needed vs SABA monotherapy.5,6 All 3 cited RCTs used budesonide-formoterol formulations.

For moderate and severe asthma, requiring step 3-4 and step 5 treatment, respectively, the GINA 2021 guidelines recommend ICS-formoterol inhaler maintenance and reliever therapy (MART; also referred to as single maintenance and reliever therapy [SMART]) as the preferred approach. Data suggest a decreased exacerbation risk of 32% (ARR, 6.4%) for patients with moderate asthma who used MART therapy compared with the same dose of ICS-LABA maintenance controller therapy. There is no direct evidence comparing MART and maintenance ICS plus SABA regimens for the severe asthma group.8

Benefits and Harms

Treatment using a single ICS-formoterol inhaler for both maintenance and rescue symptom relief provides a streamlined, effective approach for improving asthma care and also enables patients to self-titrate ICS according to symptom severity. Although the guidelines strongly advocate for the use of ICS-formoterol with robust evidence for reduced exacerbation risk, this treatment regimen may not be optimal for all patients. This led GINA to provide the “alternative track.” Although ICS inhalers are safe and there was no increased risk of adverse effects among those assigned to the ICS-formoterol as-needed groups in the studies cited above, certain individuals may be more susceptible to adverse effects such as dysphonia or thrush and have difficulty tolerating ICS, compared to therapy without ICS.

Discussion

The 2020 NAEPP guidelines still recommend SABA monotherapy for step 1 asthma treatment; however, SABA alone does not address underlying airways inflammation leading to asthma pathophysiology. Convincing data to suggest reduced morbidity and mortality with ICS have led GINA to advocate for the addition of ICS in all asthma treatment plans since 2019. Evidence from multiple RCTs supports the use of ICS-formoterol as the preferred maintenance and reliever therapy in the treatment of patients with mild or moderate asthma. Regardless of the chosen treatment track, GINA guidelines recommend careful attention be paid to ensuring that patients have ICS as part of their regimen to prevent harm caused by overreliance on SABA monotherapy. Careful assessment for alternative diagnoses, modifiable risk factors, and incorrect inhaler technique remain critical in asthma care.

Areas Needing Future Study or Ongoing Research

With a few exceptions, most studies of single maintenance and reliever therapy have used budesonide-formoterol. The guideline recommendations include other ICS-formoterol formulations; however, more data supporting this approach would be welcome. While the current literature demonstrates the advantage of ICS-formoterol as reliever therapy and MART therapy, access to and cost of these medications remain a barrier to guideline implementation.9 Clinician implementation remains a barrier to guideline adherence, as demonstrated by survey data from 736 primary care clinicians in Australia, Canada, China, and the Philippines, indicating that while 70.3% were aware of these guidelines, 47.4% would still consider SABA monotherapy for initial therapy of mild asthma.10 Research into ways to overcome this barrier is needed.

Source: JAMA

Longer duration of exclusive breastfeeding appears protective against childhood asthma


Infants who exclusively breastfed for longer durations experienced lower odds for developing asthma compared with other infants, according to a study published in Annals of Allergy, Asthma & Immunology.

These results extend the understanding of the association between breastfeeding and respiratory healthKeadrea Wilson, MD, pediatrician in the division of neonatology, department of pediatrics, at The University of Tennessee Health Science Center in Memphis, and colleagues wrote.

woman breastfeeding her baby

The researchers examined data from 2,021 maternal-child dyads enrolled in the NIH ECHO-PATHWAYS consortium drawn from three prospective pregnancy cohorts.

Within the maternal population, 38% of women identified as Black, 52% as white and 6% as Hispanic/Latina. Also, 44% reported an education level of high school or less. There were few women who smoked during pregnancy as well (range among the cohorts, 3%-9%).

The population of children was 50% female, with 42% classified as first-born children and 34% born via cesarean delivery. At birth, the median gestational age was 39.29 weeks (interquartile range [IQR], 38.43-40.14 weeks).

Questionnaires conducted when the children were aged 4 to 6 years (IQR, 4.1-4.5 years) asked mothers about durations of any and exclusive breastfeeding.

Also, the International Study of Asthma and Allergies in Childhood and other questionnaires assessed child wheeze and asthma outcomes as well as asthma-specific medication use and diagnosis, leading the researchers to consider current wheeze, ever asthma, current asthma and strict current asthma in their outcomes.

Overall, 16% of the children had current wheeze, 12% had ever asthma, 12% had current asthma and 9% had strict current asthma.

Among the children, 33% were never breastfed or breastfed for less than 2 months, 13% were breastfed for 2 to 4 months, 9% were breastfed for 5 to 6 months and 45% were breastfed for more than 6 months.

Also, 68% of the women who breastfed their child for more than 6 months were white, and 78% had more than a high school education.

The researchers did not find any association between the duration of breastfeeding and child wheeze or asthma outcomes. Although there was no statistical significance in the overall adjusted association for ever asthma, the researchers found a significant linear trend toward protection (P = .034).

Researchers observed decreased odds for ever asthma among children breastfed for 2 to 4 months (adjusted OR = 0.79; 95% CI, 0.49-1.24), 5 to 6 months (aOR = 0.72; 95% CI, 0.42-1.25) and longer than 6 months (aOR = 0.65; 95% CI, 0.43-0.97) compared with children breastfed for less than 2 months.

Also, there was an association between longer duration of exclusive breastfeeding and decreased odds for current asthma for 2 to 4 months (aOR = 0.64; 95% CI, 0.41-1.02), 5 to 6 months (aOR = 0.61; 95% CI, 0.38-0.98) and longer than 6 months (aOR = 0.52; 95% CI, 0.31-0.87) of exclusive breastfeeding compared with less than 2 months.

The researchers further found protective associations for current wheeze, ever asthma and strict current asthma with more than 6 months of exclusive breastfeeding compared with less than 2 months of exclusive breastfeeding and with never to less than 2 months of any breastfeeding.

Researchers also reported linear trends with longer duration of exclusive breastfeeding and current wheeze, ever asthma (P = .005), current asthma (P = .009) and strict current asthma (P = .018).

Additionally, the researchers found no statistically significant interactions between mode of delivery and duration of any breastfeeding on child wheeze or asthma outcomes.

However, dyads with vaginal deliveries had consistently stronger protective associations for child wheeze and asthma outcomes based on breastfeeding duration, compared with cesarean deliveries, although the differences did not reach statistical significance.

Also, the protective effect of longer breastfeeding duration appeared restricted to mothers who did not have asthma, with an adjusted OR of 0.58 (95% CI, 0.37-0.92) for breastfeeding longer than 6 months vs. less than 2 months, but not among the children of mothers with asthma (aOR = 1.49; 95% CI, 0.79-2.8).

The researchers called their findings evidence of protective associations between exclusive breastfeeding continued for longer durations and child asthma outcomes, although when considering the duration of any breastfeeding, there was no strong association between subsequent development of wheeze or asthma apart from ever asthma.

Antibiotic use before cesarean delivery does not increase asthma, eczema risks


The administration of antibiotics before cesarean delivery did not increase the risks for asthma, eczema or other allergic conditions in early childhood, providing further support for their use, according to a study published in The BMJ.

“Women who give birth by cesarean section are at increased risk of infections, such as wound infections, in the period after giving birth, and prophylactic antibiotics are used to reduce this risk,” Dana Sumilo, DPhil (Oxon), MFPH, honorary clinical research fellow at the Institute of Applied Health Research and fellow of the faculty of public health at University of Birmingham in the United Kingdom, told Healio.

mother and newborn baby
Source: Adobe Stock

Providing antibiotics to the mother before skin incision instead of after the cord has been clamped can reduce these risks even further, Sumilo continued, prompting the National Institute for Health and Care Excellence to update its guidance in 2011.

“Preventative antibiotics, if given before cord clamping, can cross the placenta and affect microbes that colonize the baby’s gut. Gut microbiota include bacteria that are thought to play a role in the development of the immune system,” Sumilo said.

Previous studies have implicated disruptions in gut microbiota and antibiotic use in susceptibility to conditions related to allergy such as asthma and eczema, Sumilo said.

“Although there are no known health harms from pre-incision antibiotics for cesarean section to newborns, until now there have been no studies looking at longer term outcomes,” she said.

The researchers conducted an observational controlled interrupted time series study of linked health care records of mothers and their babies born between 2006 and 2018 in the U.K. covering a period before and after the change in policy.

Records included 515,945 mother-baby pairs from the Health Improvement Network and Clinical Practice Research Datalink databases, where 28.1% of births were cesarean, and 3,945,351 mother-baby pairs in the Hospital Episode Statistics (HES) dataset, where 25.4% of births were cesarean.

Children who were exposed to pre-incision prophylactic antibiotics experienced a 9% decrease in asthma diagnosis (incidence rate ratio [IRR] = 0.91; 95% CI, 0.78-1.05) and a 2% decrease in eczema diagnosis (IRR = 0.98; 95% CI, 0.94-1.03) compared with those who were not exposed, although these differences did not reach statistical significance. Sensitivity analyses for asthma and eczema produced fairly similar results to the primary analyses, the researchers added.

Also, the researchers found no evidence of a significant difference in risks for other allergic or allergy-related conditions, autoimmune health conditions, infections or less specific child health measures.

Children exposed to pre-incision prophylactic antibiotics in the HES dataset experienced a 5% increase in first-time hospital admissions for asthma (IRR = 1.05; 95% CI, 0.99-1.11) and a 4% decrease in admissions for eczema (IRR = 0.96; 95% CI, 0.71-1.29) compared with those who were not exposed, but again these differences were not statistically significant.

There were no significant differential effects based on whether caesarean deliveries were elective or emergencies, nor was there any evidence that different antibiotic regimens had a differential effect on risk for asthma hospital admissions or necrotizing enterocolitis.

“Our study found no evidence of a link between the policy change to offer prophylactic antibiotics before skin incision for caesarean section and asthma, eczema and other allergic and allergy-related health conditions in early childhood,” Sumilo said.

“Our findings provide further evidence for the current policy in the U.K. to administer prophylactic antibiotics for cesarean section before skin incision and discussion regarding the timing of prophylactic antibiotics for cesarean section,” she continued.

However, the researchers cautioned that their results may not be generalizable to settings with different prophylactic antibiotic regimens or to babies who were delivered vaginally.

“Further studies are needed to confirm our findings in older children and in other populations and settings using different prophylactic antibiotic regimens for cesarean section,” Sumilo said.

Lebrikizumab shows promise in adolescents with uncontrolled asthma


Lebrikizumab reduced exacerbations in adolescents with uncontrolled asthma and had a favorable safety profile, according to results of the ACOUSTICS study.

The study, which was stopped early by the sponsor, showed a greater treatment effect with the higher dose of lebrikizumab studied.

Doctor female patient teen_Adobe Stock_188725706

Stanley JSzefler, MD, researcher in the department of pediatrics at the Children’s Hospital Colorado and University of Colorado School of Medicine, reported results from the phase 3, multicenter, randomized, double-blind, placebo-controlled ACOUSTICS study at the American Thoracic Society International Conference. The trial aimed to evaluate efficacy, safety and tolerability of lebrikizumab (Eli Lilly).

The study enrolled 346 adolescents aged 12 to 17 years with uncontrolled asthma despite daily use of an inhaled corticosteroids and at least one other controller medication. Those enrolled also had a prebronchodilator FEV1 of 40% to 90% predicted, a bronchodilator response of 12% or more and were on stable background therapy. Patients were randomly assigned to receive lebrikizumab 125 mg (n = 75) or 37.5 mg (n = 58) or placebo (n = 91) subcutaneously once every 4 weeks. The trial was designed to be a 52-week study. Szefler presented results from 224 (65%) of adolescents who completed the 52-week placebo-controlled period.

The primary outcome was asthma exacerbation rate during the study period. Researchers also assessed time to first asthma exacerbation and safety outcomes.

At baseline, median blood eosinophil count was 295 cells/µL. Compared with the placebo group, patients assigned lebrikizumab 125 mg had a 51% (adjusted RR = 0.49; 95% CI, 0.28-0.83) reduction in exacerbation rates and those assigned 37.5 mg had a 40% (aRR = 0.6; 95% CI, 0.35-1.03) reduction, according to the data presented.

The reduction in asthma exacerbation rates with lebrikizumab compared with placebo was greatest in those with baseline blood eosinophil counts of 300 cells/µL or more. In those with blood eosinophil counts of 300 cells/µL or more, the lebrikizumab 125 mg group had a 56% (RR = 0.44; 95% CI, 0.21-0.89) reduction in asthma exacerbation rates and those assigned 37.5 mg had a 58% (RR = 0.42; 95% CI, 0.19-0.93) reduction, according to the results.

Compared with the placebo group, patients assigned lebrikizumab had increased time to first asthma exacerbation for both 125 mg dose (HR = 0.37; 95% CI, 0.21-0.66) and the 37.5 mg dose (HR = 0.4; 95% CI, 0.22-0.73).

The mean number of lebrikizumab doses was 10.2 over 41 weeks. Most adverse events that occurred during the study were non-serious, mild to moderate in severity and did not lead to discontinuation of the study drug, according to the results. Eosinophil-associated treatment-related adverse events reported included decreased neutrophil count and eosinophil; there were no cases of eosinophilic granulomatosis with polyangiitis.

“In terms of safety, it was pretty comparable to what was seen in the adult studies to date,” Szefler said.

“Looking at the data … in terms of biomarkers, there was a very positive signal,” Szefler said. “Eli Lilly purchased the drug. They’re evaluating it now; they continue to study [lebrikizumab] with atopic dermatitis … [that] used higher doses and greater frequency. So, Eli Lilly is now taking a step back looking at those studies, and then deciding whether or not to pursue this. It has been interesting when I look at the inner-city asthma consortium studies, there seems to be fairly high signals for IL-13 gene activation. So, I think there’s some promise here.”

The researchers concluded that, despite the lack of a consistent dose response, post hoc analyses of adult studies (LAVOLTA I and II, MILLY) showed similar results. In addition, recently reported data from phase 3 trials of lebrikizumab in adolescents and adults with atopic dermatitis demonstrated clinical efficacy using higher doses with greater frequency, according to the researchers. Future study in asthma may need to look at optimal use of lebrikizumab with higher and more frequent dosing in patients with type 2 inflammation at risk for exacerbations, the researchers concluded.

Epinephrine (adrenaline) compared to selective beta-2-agonist in adults or children with acute asthma: a systematic review and meta-analysis


Abstract

Background International asthma guidelines recommend against epinephrine (adrenaline) administration in acute asthma unless associated with anaphylaxis or angio-oedema. However, administration of intramuscular epinephrine in addition to nebulised selective β2-agonist is recommended for acute severe or life-threatening asthma in many prehospital guidelines. We conducted a systematic review to determine the efficacy of epinephrine in comparison to selective β2-agonist in acute asthma.

Methods We included peer-reviewed publications of randomised controlled trials (RCTs) that enrolled children or adults in any healthcare setting and compared epinephrine by any route to selective β2-agonist by any route for an acute asthma exacerbation. The primary outcome was treatment failure, including hospitalisation, need for intubation or death.

Results Thirty-eight of 1140 studies were included. Overall quality of evidence was low. Seventeen studies contributed data on 1299 participants to the meta-analysis. There was significant statistical heterogeneity, I2=56%. The pooled Peto’s OR for treatment failure with epinephrine versus selective β2-agonist was 0.99 (0.75 to 1.32), p=0.95. There was strong evidence that recruitment age group was associated with different estimates of the odds of treatment failure; with studies recruiting adults-only having lower odds of treatment failure with epinephrine. It was not possible to determine whether epinephrine in addition to selective β2-agonist improved outcomes.

Conclusion The low-quality evidence available suggests that epinephrine and selective β2-agonists have similar efficacy in acute asthma. There is a need for high-quality double-blind RCTs to determine whether addition of intramuscular epinephrine to inhaled or nebulised selective β2-agonist improves outcome.

Allergists provide specialty asthma care by identifying triggers, educating patients


As the medical community celebrates Asthma and Allergy Awareness Month this May, the American College of Allergy, Asthma & Immunology reminds clinicians and patients alike that allergists are key to successful asthma treatment.

“Allergists are board certified asthma specialists,” Jonathan L. Bayuk, DO, vice chair of the ACAAI Payer and Managed Care Committee and president of Allergy & Immunology Associates of New England in Springfield, Massachusetts, told Healio.

According to a report from ACAAI titled Asthma Management and the AllergistBetter Outcomes at Lower Costallergist management of asthma improves patient outcomes while reducing treatment costs for payers and indirect costs for society. It also leads to fewer hospitalizations and other emergency interventions, fewer missed days of work and school and significantly better health and quality of life.

Jonathan L. Bayuk

“Nine percent of people in Massachusetts have asthma, and that bears out across the country,” said Bayuk, who also is the division chief of allergy and immunology at Baystate Medical Center and assistant professor of medicine at UMass Chan Medical School.

The 25 million people with asthma in the United States — or 7.9% of the nation’s population — include 6.1 million aged younger than 18 years and account for an average of 3,168 deaths per year. But despite scientific advances, ACAAI said, asthma’s prevalence has increased.

“If you look at all the changes in medication that we’ve had, we’re still not further along, and that’s frustrating,” Bayuk said. “At some point, it’s not just about creating new drugs. It’s really about changing the way that health care looks at asthma.”

Changing the approach

Guidelines encourage clinicians to diagnose asthma as early as possible and aggressively treat it when it is still mild to achieve control. Allergists are best equipped to provide these diagnoses and courses of treatment, according to ACAAI’s report.

Guidelines from the National Heart, Lung and Blood Institute and Global Initiative for Asthma as well as other national organizations recommend referral to specialists in many cases, although some health care plans make these referrals difficult.

“An allergist will focus on identifying the triggers, as much of asthma and asthmatic disease is allergic,” Bayuk said, adding that unlike many primary care providers, allergists often respond with biologics.

“Most patients in my area do not want to be on any medication, so we use immunotherapy or allergy shots, which could be extremely effective in reducing asthma symptoms and, in some cases, remove them from having any problems at all,” he said.

Patient education is a significant part of this process as well, as Bayuk said that allergists are especially good at explaining the immunology behind asthmatic reactions.

“Identify the triggers, try to eliminate as much as you can, optimize the medication and then educate the patient — what the problem is, why it happens, what can be done about it, how the patient can participate, which is vital to their own care, and have regular follow-up,” Bayuk said.

A preventive approach to asthma is preferable to waiting for exacerbations to occur and then sending the patient to the ED for oral steroids, Bayuk said, which may have side effects including weight gain, permanent changes to bones, increased fat in unsafe areas such as organs, increased diabetes risks and possibly even psychosis.

“That’s just a very poor way to manage it,” Bayuk said. “Steroids work. I certainly use them if I have to. But they’re definitely overused in settings where someone isn’t being managed properly. That’s not a good approach, and we know that to be true.”

Beyond the office

Outside the examination room, allergists can play a role in educating the community.

“I’ve been involved in many asthma awareness days, programs and fairs over the years, a lot of times focusing on children so they get education as early as possible,” Bayuk said. “Those efforts can be helpful because they educate in a way that is not just sitting in a doctor’s office.”

Though these events no longer use spirometry as part of their screening processes due to the COVID-19 pandemic, Bayuk said, he has incorporated breathing instruction into his presentations.

“It’s an obstructive disease, meaning that you can get air out but it still feels like you can’t breathe,” he said. “There are some breathing techniques that can be taught that can help people get through their asthma problems and strengthen their lungs as well.”

Despite these efforts, challenges remain at the system level.

“There’s a tremendous shortage of staffing in health care right now — nursing staff, medical assistant staff, ancillary health and physicians. In the last year, I would say at least 10% to 15% of our primary care service in this area has retired,” Bayuk said.

When patients do connect with PCPs, Bayuk continued, they often are dealing with other physical issues such as diabetes and hypertension or mental disorders such as depression or anxiety, in addition to other problems.

“At the end of the visit, the doctor may ask, ‘How’s your asthma?’ And the patient will say ‘It’s fine,’ and that’s it,” Bayuk said. “Patients definitely underestimate their asthma. They don’t necessarily know that the way that they feel is abnormal and that they need to address it.”

Furthermore, patients often get treatment for asthma exacerbations at urgent care centers and EDs, which then refer patients back to their primary care doctors instead of to an allergist.

“They just don’t have that direct connection,” Bayuk said. “That’s a big obstacle. So, I spend time in emergency rooms educating emergency department providers but, again, the system is overloaded, and there are other priorities that take precedence over asthma.”

Plus, regardless of their level of insurance coverage, patients struggle with affording medication.

“If their options are fighting through it with whatever they can get until they have an exacerbation or going to an emergency room vs. spending several hundred dollars a month for preventive medicines that work, they will often choose the former,” Bayuk said.

Environment plays a role in these asthma cases too, as Bayuk noted many residents of Springfield who live in apartment buildings that contend with dust mites, cockroaches, mold, mice and other triggers that are beyond his patients’ control.

“Their asthma is taken care of by community centers and urgent care centers and sometimes not taken care of at all,” he said. “So, they end up having a lot of asthma exacerbations. Hospitals, as hard as they try, sometimes are unable to look at that preventive piece, and that’s across the country.”

The role of collaboration

Bayuk believes that hospitals and outpatient providers need to collaborate and that primary care doctors should understand the role of allergists and what they can do in providing asthma care.

“Many patients tell me ‘I can’t believe I haven’t come here before. I was never told this was an option,’” Bayuk said.

Patients with asthma who are managed by specialists report significantly higher general physical and asthma-specific quality of life, according to ACAAI. But in addition to achieving better patient care, these referrals improve the bottom line too.

Each dollar invested in asthma control programs could save $71 in health care expenses as care shifts from costly hospital and ED settings to doctor’s offices and outpatient clinics, according to data from ACAAI.

Additionally, managed care leads to higher ratings for quality of care, fewer restrictions in activities, improved physical function, fewer unscheduled visits for asthma care and less overuse of beta agonist medications, among other personal and systemic improvements.

Now, Bayuk is working with colleagues at Baystate Medical Center in Northampton, Massachusetts to identify patients who are frequently treated for asthma at the center and connect them with allergist care.

“We’re trying to find a way to make it relatively easy for the emergency room provider or the urgent care provider to identify these patients and then have them referred to get further evaluations,” he said.

“If we could find a way for that to be much more efficient, how we take care of these folks, once they land in the hands of a well-trained person who understands how to take care of asthma, it could change their life,” he said.

These efforts should not stop with one collaborative program at one hospital either, Bayuk said.

“The way that America looks at chronic disease needs to change so we can help people live healthier, happier lives,” he said. “It’s better not just for them, but the health care system can save resources, make people’s lives better and prevent morbidity and mortality.”

For more information:

Jonathan L. Bayuk, DO, can be reached at jbayuk@yahoo.com.

Reference:

Breastfeeding reduces risk for lower respiratory tract infections, asthma in infants


Breastfeeding mitigated the risks for developing lower respiratory tract infections in infancy and for developing asthma and allergic rhinitis in childhood, according to a study published in The Journal of Allergy and Clinical Immunology.

“The impact of breastfeeding on certain childhood respiratory diseases is still controversial, with some studies actually showing that breastfeeding could increase the risk for some chronic lung diseases in children, such as asthma,” Christian Rosas-Salazar, MD, MPH, assistant professor of pediatrics at Vanderbilt University Medical Center, told Healio.

To better understand the effect of breastfeeding on pediatric respiratory health, Rosas-Salazar and colleagues evaluated data of 1,949 healthy infants (median age, 55 days; interquartile range [IQR], 16-78 days; 47.67% girls; 65.11% non-Hispanic white; 31.4% born via cesarean section) in a population-based cohort who were followed via passive and active surveillance, including in-person respiratory illness visits and viral testing, between November and March of their first year. Only 1,495 (76.71%) of the enrolled infants had 4-year data available.

The researchers also monitored cytokines in the upper respiratory tract (URT) and gut microbiomes of these infants, while parents reported the type of feeding they provided their infants as well as the duration of any breastfeeding.

The median duration of exclusive breastfeeding among the total infants enrolled was 6 weeks (IQR, 0-20 weeks).

The URT and gut microbiomes of the infants who had been exclusively breastfed had the lowest values of alpha diversity metrics at enrollment. Also at enrollment, the beta diversity of the URT and gut microbiomes differed by type of feeding (< .01), and there were multiple differences in the abundance of URT and gut genera by type of feeding.

The researchers additionally found associations between the type of breastfeeding and the levels of pro-inflammatory cytokines but not with levels of pro-allergic cytokines.

Overall, 440 infants (22.58%) developed a lower respiratory tract infection (LRTI) during infancy, 209 (10.72%) developed a 1-year food sensitization, 286 (14.67%) developed 4-year current asthma and 516 (26.48%) developed 4-year ever allergic rhinitis.

Analyses also showed a dose-response effect of the type of feeding at enrollment on an LRTI in infancy and 4-year current asthma, with infants who were exclusively breastfed at enrollment having the lowest odds of these outcomes. However, there was no association between type of feeding at enrollment with 1-year food sensitization or 4-year ever allergic rhinitis.

Additionally, the duration of exclusive breastfeeding had a protective dose-response effect on LRTI in infancy, 4-year current asthma and 4-year ever allergic rhinitis. Each 4 weeks of exclusive breastfeeding decreased the odds of an LRTI in infancy (OR = 0.95; 95% CI, 0.91-0.99), 4-year current asthma (OR = 0.95; 95% CI, 0.9-0.99) and 4-year ever allergic rhinitis (OR = 0.95; 95% CI, 0.92-0.99) by approximately 5%.

Exploratory analyses further showed a significant mediating effect of the beta diversity of the gut microbiome, but not of the URT microbiome, on the association between exclusive breastfeeding and 4-year current asthma.

The beta diversity of the early-life URT and gut microbiomes, as well URT cytokines in infancy, did not show any mediating effects on the associations between exclusive breastfeeding and other clinical outcomes.

Christian Rosas-Salazar

“The results of our study suggest that exclusive breastfeeding protects against the risk for lower respiratory tract infections such as bronchiolitis or pneumonia, asthma and hay fever in young children,” Rosas-Salazar said. “Furthermore, we show that these effects are likely due to the impact of exclusive breastfeeding on the early-life microbiome.”

Noting these benefits, the researchers recommended that doctors discuss the effects of breastfeeding on respiratory health with their patients.

“Health care providers should continue to strongly recommend exclusive breastfeeding to their patients, and they can add the protective effects of exclusive breastfeeding on common childhood respiratory diseases as one of the potential benefits,” Rosas-Salazar said.

Longer durations of exclusive breastfeeding likely offer the most protection, the researchers continued, with nonexclusive breastfeeding in the first few months possibly offering benefits as well.

“Understanding if exclusive breastfeeding impacts the development of lung diseases in older children or even adults is an important next step of our study,” Rosas-Salazar said.

FDA approves first generic of Symbicort for asthma, COPD


The FDA announced approval of the first generic of Symbicort — budesonide and formoterol fumarate dihydrate — Inhalation Aerosol for the treatment of asthma and COPD, according to an agency press release.

The complex generic drug-device combination product is a metered-dose inhaler. The generic is approved for treatment of asthma in patients aged 6 years and older and for maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD, including chronic bronchitis and/or emphysema, according to the release. It should not be used to treat acute asthma exacerbations, according to the FDA.

FDA approved
Source: Adobe Stock.
“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” Sally Choe, PhD, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, said in the release. “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”

The metered-dose inhaler contains the corticosteroid budesonide and the long-acting bronchodilator formoterol. Two inhalations, twice daily, treat both asthma and COPD by preventing symptoms. The inhaler is approved for 160/4.5 mcg/actuation and 80/4.5 mcg/actuation, according to the release.

The most common side effects associated with budesonide and formoterol fumarate dihydrate oral inhalation aerosol are nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting and oral candidiasis for patients with asthma. The most common side effects of this treatment among patients with COPD are nasopharyngitis, oral candidiasis, bronchitis, sinusitis and upper respiratory tract infection, according to the release.

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals.

Complex products are medical products where uncertainty concerning the approval pathway or possible alternative approaches to product development can benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products, according to the release. The FDA noted that since drug-device combination products can be more challenging to develop, fewer exist, resulting in less market competition. The FDA said addressing the challenges related to complex generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and its efforts to promote patient access and more affordable medications, according to the release.