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Management of Moderate

to Severe Asthma

Approval code: Y1-0924 Expiry date: Jan 2026


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ASTHMA FACTS
Asthma Has a Worldwide Burden:
one of the leading causes of hospital admissions1

Asthma exacerbations may be physically threatening and emotionally significant for patients; one-third of
patients reported having an asthma exacerbation so bad, that they thought their lives were in danger. 2

There are approximately In 2019, across 219 countries,


262 million asthma exacerbations accounted for3

patients in the world with asthma.3 455,000 Deaths.

References: 1. Inpatient Discharges [2021], Ontario Ministry of Health and Long-Term Care, IntelliHEALTH ONTARIO, Date Extracted: [January 15, 2023]. 2. Sastre J, et
al. World Allergy Organ J. 2016;9:13. 3.
Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet.
2020;396(10258):1204-22.
Asthma Prevalence in Gulf Countries

The prevalence of asthma was ~7.6% within the Gulf cluster.1*

25.9%2* 10.8%2
Kuwait Bahrain

The prevalence of asthma was


Qatar
19.8%2 10.3%2
UAE higher in KUWAIT, QATAR & KSA
than in other countries.1,2

KSA 17.6% 2 14.15%2


Oman

*Gulf cluster countries including Kuwait, Saudi Arabia and the UAE..

References: 1. Noibi S., Mohy A., Gouhar R., Shaker F., Lukic T. and Al-Jahdali H. (2020). Asthma control factors in the Gulf Cooperation Council
(GCC) countries and the effectiveness of ICS/LABA fixed dose combinations: a dual rapid literature review. BMC Public Health, 20(1), pp.1-16. 2.
Masjedi, M., Ainy, E., Zayeri, F. and Paydar, R. (2018). Assessing the Prevalence and Incidence of Asthma and Chronic Obstructive Pulmonary
Disease in the Eastern Mediterranean Region. Turkish Thoracic Journal, 19, pp.56-60.
Asthma Is a Chronic Inflammatory Disease with Recurring Flare-Ups
of Inflammation (Cause) and Symptoms (Consequence) 1-3

Pathology of Asthma4
Air trapped in alveoli
Constricted smooth muscle
Relaxed smooth muscle

Wall inflamed and thickened

A. Normal Airway B. Diseased Airway Diseased Airway in Exacerbation

Bronchial mucosal specimens of a


healthy person (A) and a patient
with mild asthma (B)1

References: 1. Busse WW et al. N Engl J Med. 2001; 344:350-362; 2. Beasley R et al. J Allergy Clin Immunol. 1993;92:148–154; 3. Global Initiative for Asthma. Updated
2020. www.ginasthma.org. Accessed February 2021; 4. Asthma. http://www.physio-pedia.com/Asthma. Accessed July 30, 2018.
Factors That Contribute to Asthma Exacerbations

Viral
respiratory
infections1
Bacterial Allergen
infections1 exposure1

Asthma Asthma exacerbation


can be triggered by
Stress3 Exacerbation Air multiple factors.
Pollution1

Occupationa
Exercise / l exposures1
cold air2

References: 1. Asthma exacerbations. 2: aetiology. Singh AM, Busse WW. Thorax. 2006;61:809–816. 2. Exercise-Induced Bronchoconstriction (EIB). (n.d.).
American College of Allergy, Asthma & Immunology. Retrieved June 9, 2022, from
https://acaai.org/asthma/types-of-asthma/exercise-induced-bronchoconstriction-eib/. 3. https://www.asthmaandlung.org.uk/conditions/asthma/asthma-triggers/
stress.
A Lot Going on Beneath the Surface

Symptoms

Airflow Obstruction1

Bronchial Hyperresponsiveness1

Airway Inflammation1

Reference: 1. Holgate ST, Thomas M. Chapter 7 - Asthma. Middleton’s Allergy Essentials. Elsevier; 2017:151-204.
Patterns and Hazards of SABA
OVERRELIANCE
& OVERUSE
Factors Leading to Asthma Deaths

SIGN 141 ● British Guideline on the Management of Asthma


A National Clinical Guideline October 2014

• Inadequate treatment with inhaled corticosteroids.


• Heavy and increasing use of beta2-agonists.
• Inadequate follow-up.
• Inappropriate prescription of beta-blockers & NSAIDs (failure to ask about past reactions).
Clinical A Socio-Economic burden of asthma
in the Gulf
Results from SABINA III Study*

Asthma represents a major public health concern in the Gulf


Results serve as a call to action for HCPs and policy makers to ensure
clinical practice aligns with the latest treatment recommendations

58.5% of patients were prescribed ≥3 SABA canisters

13.3% of patients purchased SABA over-the-counter

51.2% of patients had partially controlled/uncontrolled asthma

41.9% of patients experienced ≥1 severe asthma exacerbation

A cross-sectional study was conducted at 16 sites across Kuwait, Oman, and the UAE. Data from 301 patients with asthma were recruited between
May and December 2019, 54.5% of whom were treated by respiratory specialists. Values in the 12 months preceding a single study visit.
Alzaabi et al. Asthma Research and Practice (2022) 8:3.
SABA overuse is a universal asthma problem
The SABINA programme is the largest real-world observational data
analysis1 on SABA usage and demonstrated:2

3 or more SABA canisters/year is associated with SABA overuse is a widespread problem regardless
an increased risk of exacerbations3-5 of country, asthma severity and ICS therapy 3-5

of patients PRESCRIBED 3 OR MORE SABA CANISTERS/YEAR6 in MODERATE AND SEVERE


ASTHMA PATIENTS

of patients HAD PARTIALLY CONTROLLED OR UNCONTROLLED ASTHMA

of patients EXPERIENCED AT LEAST 1 SEVERE EXACERBATION IN THE 12 MONTHS


PRECEDING THEIR STUDY VISIT

MORE EXACERBATIONS7 in patients WITH 3 OR MORE CANISTERS/YEAR


(vs 1-2 canisters/year) and IS INDEPENDENT OF ICS USE
Adjusted IRR 95% CI, 1,32 [1.18, 1.49] among GINA 2-5 patients with ≥50% annual coverage of ICS-containing therapies

Considering SABA overuse is universal and consistent, are your asthma patients at risk?
SABA overuse defined as 3 or more canisters prescribed or in possession6
CI= Confidence Interval, GINA= Global Initiative for Asthma, ICS= Inhaled Corticosteroids, IRR= Incidence Rate Response, SABA= Short-Acting Beta-Agonists.

1. SYMBICORT Turbuhaler 160/4.5 μg, Inhalation powder. Patient Information Leaflet. 2. Cabrera CS, et al. Eur Resp J. 2020.
https://doi.org/10.1183/13993003.01858-2019. 3. Bloom CI, et al. Adv Ther. 2020;37:4190-4208. 4. Nwaru BI, Ekström M,
Hasvold P, et al. Eur Respir J 2020; 55: 1901872. 5. Quint J, Arnetorp S, Janson C, et al. ERS 2020; September 7-9, 2020. P2629.
6. Alzaabi A et al. Asthma Res Pract. 2022;8(1):3. 7. Quint JK, et al. J Allergy Clin Immunol Pract 2022;S2213-2198(22)00285-9.
In Asthma, ICS are an Essential Part of the Treatment
to Control the Inflammation and Reduce Mortality

Relationship between mortality rates and SABA or ICS use

A nested case-control study of 129 cases and 655 control subjects A nested case-control study of 66 subjects who died of asthma for
selected from a cohort of 12301 users of asthma drugs followed during whom there were complete data with 2681 controls.
the period 1980 through 1987.

ICS= Inhaled Corticosteroid; SABA= Short-Acting β2-Agonist.

References: 1. Suissa S et al. Am J Respir Crit Care Med 1994; 149:604-10. 2. Suissa S et al. N Engl J Med 2000;343:332-6.
GINA 2023:
What’s new?
Approach to Asthma
Management
Primary Considerations in Managing Asthma

Pathology Clinical Course

• Episodic bronchospasm. • Acute episodic.


• Inflammation in airways. • Long-term risk.

Pharmacologic Approach Treatment Strategy

• Bronchodilators. • Symptom control (current).


• Anti-inflammatory drugs (ICS). • Preventing risk.
GINA 2021: Asthma Management
Targets Both Current Symptom Control and Risk of Exacerbations

Achieve and maintain best possible symptom control Target: Reduction of risk

Symptom control Future risk

defined by defined by

Persistent
Symptoms Reliever use Exacerbations
airflow limitation
Lung Adverse effects
Activity Lung function
function of medication

Reference: 1. Global Initiative for Asthma: 2021.


GINA 2023: Asthma Management
Focuses on symptom control and risk reduction

Personalized asthma management involves a continual cycle of assessment, adjustment of treatment and review.

Reference: . Global Initiative for Asthma: 2023; Box 3.2, p 50.


GINA 2023 Assessment of Asthma Control

Reference: 1. Global Initiative for Asthma: 2023; Box2-1, P35..


Patient A is a Moderately Severe Asthma patient
who over-relies on his SABA vs. ICS/LABA

PATIENT A,* is diagnosed with asthma and has been


prescribed
ICS/LABA and SABA.

Despite experiencing cough, chest tightness, and wheezing, Patient A


is still not adherent to his ICS/LABA.
Patient A relies on his SABA to relieve his symptoms
and uses more than 3 canisters of SABA per year.
Patient A suffered from exacerbation twice last year.

Why would Patient A’s behavior put him at risk?

*Fictitious patient.
ICS= inhaled corticosteroids; LABA= long-acting beta-agonists; SABA= short-acting beta-agonists.
A Real-World Study Has Shown That, Across All Asthma
Severities, Patients Use SABA Reliever Therapy Over
Their ICS

A real-world study involving 2,050 adult


patients in seven European countries has
shown that, across all asthma severity,
patients use SABA reliever therapy over
their ICS.1

Within a 1-month period, nearly two-


thirds of patients had used reliever
inhalers whereas only 23% had used ICS
regularly.1

SP= severe persistent; MOP= moderate persistent; MP= mild persistent; MI= mild intermittent.
Reference: 1. Rabe KF, et al. Eur Respir J. 2000;16:802-807.
In Asthma, ICS Are an Essential Part of the
Treatment
to Control the Inflammation and Reduce Mortality

Relationship between mortality rates and SABA or ICS use

How would we use


Patient A’s natural
relief-seeking
behavior to better
control his asthma?

A nested case-control study of 129 cases and 655 control subjects A nested case-control study of 66 subjects who died of asthma for
selected from a cohort of 12301 users of asthma drugs followed during whom there were complete data with 2681 controls.
the period 1980 through 1987.

ICS= inhaled corticosteroid; SABA= short-acting β2-agonist.


References: 1. Salamol Easi-Breathe. Summary of Product Characteristics. 2. Humbert M, Andersson TLG, Buhl R, et al. Allergy 2008;63:1567-1580.
SYMBICORT NOW HELPS YOU IMPROVE ASTHMA MANAGEMENT
BY DELIVERING EFFICACY WHEN IT MATTERS2

SABA overuse puts patients at risk: TRADITIONAL34


SABA as need based regimen
► Asthma is a chronic inflammatory fluctuating disease with sudden flare ups.34

inflammation and symptoms*1


SABA (e.g. salbutamol)
► When symptoms get worse patients reach for their SABA for fast relief. 34

Relative magnitude of
Oral corticosteroids
Inflammation
► SABA reliever does not address increased inflammation: 34
Symptoms

≥3 canisters/year is associated with an increased risk of exacerbations


and mortality18 Time days

NEW & PREFERRED34


Symbicort Anti-Inflammatory Reliever helps moderate budesonide-formoterol as need based regimen

and severe patients: BUD/FORM anti-inflammatory reliever

inflammation and symptoms*1


Relative magnitude of
Reduced exacerbation risk

► It's AS FAST AS SABA when patients seek symptom relief as-needed. 2,4,5
Inflammation
Symptoms
► NOW EVERY PUFF patients take to manage worsening symptoms ALSO treats
the root-cause inflammation PROTECTING them from exacerbations.2,4,5
Time
days

BUD/FORM= budesonide/formeterol; SABA= short-acting beta-agonists.


* Proposed hypothesis of the mechanism of a) short-acting β2-agonist (SABA) reliever and b) as-needed budesonide (BUD)/formoterol (FORM) as anti-inflammatory
reliever therapy during worsening of asthma symptoms that precedes an exacerbation. The effects of FORM are likely to be more complex and are not presented in
the graphs. SABA treats only symptoms and not the underlying inflammation. Anti-inflammatory reliever therapy treats both symptoms and the underlying
inflammation. Dashed lines indicate asthma worsening in patients with SABA reliever use.34
SYMBICORT® As-Need Based Reliever with Maintenance in Moderate
to Severe Patients, Uses Their Natural Relief Seeking Behaviour to
Reduce Exacerbations

1
ONLY ONE A preferred reliever that SUPERIOR
INHALER WORKS AS FAST IN REDUCING
with high lung deposition AS SABA EXACERBATIONS,
delivering 41.8% optimally
to relieve symptoms2- 5 vs. SABA + ICS-LABA*
sized particles
maintenance6-9
(in the range of 1–5 μm)1
1-33 minutes 21-48% 6-9

References: 1. De Boer AH, et al. Eur J Pharm Biopharm 2015;96:14351. 2. SYMBICORT® Turbuhaler 160/4.5, Inhalation powder. Summary of Product
Characteristics. 3. Seberova E and Andersson A. Respir Med 2000;94(6):607–611. 4. Ventolin EvohalerR 100. Summary of Product Characteristics. 5. Global
Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2021. Available at: http://www.ginasthma.org/ . 6. Rabe KF, Atienza T, Magyar
P, et al. Lancet 2006;368:744-753. 7. Vogelmeier C, D’Urzo A, Pauwels R, et al. Eur Respir J 2005;26:819-828. 8. Kuna P, Peters MJ, Manjra AI, et al. Int J Clin
Pract 2007;61:725–736. 9. Bousquet J, Boulet LP, Peters MJ, et al. Respir Med 2007;101:2437–2446.
SYMBICORT® Works as Fast as SABA

1-3
minutes
*

Only formoterol is proven to relieve symptoms as fast


and as effectively as salbutamol.1-3
• FEV1 values measured at 3 minutes after first dose, showed
no difference between SYMBICORT ® and salbutamol.

SYMBICORT®
uses your patients’ natural relief-seeking behaviour1
When patients have worsening symptoms, they take a
reliever.4
With SYMBICORT®, patients get fast symptom relief and
anti-inflammatory treatment WHEN they need it.4

References: 1. SYMBICORT® Turbuhaler 160/4.5, Inhalation powder. Summary of Product Characteristics. 2. Seberova E and Andersson A. Respir Med 2000;94(6):607–
611. 3. Ventolin EvohalerR 100. Summary of Product Characteristics. 4. Balanag VM et al. Pulmon Pharmacol & Ther 2006;19139-147 (v1.0).
SYMBICORT® Maintenance and Reliever Therapy

► The combination of budesonide and formoterol means that Symbicort works quickly (1-3 minutes) to relieve bronchoconstriction
while treating the underlying inflammation with every inhalation.* 1,2
► Whilst SABAs** may provide short term relief of symptoms, they do not Impact upon underlying airway inflammation or prevent
worsening of an exacerbations.3

Smooth muscle Smooth muscle


- relaxed - relaxed

RELIEVER (SABA) RELIEVER


Formoterol component shows:
Works quickly to treat
bronchoconstriction As fast an onset of action as salbutamol*
Duration of effect 4-6hrs4 Onset of action 1-3 minutes*2
Duration of effect* 12hrs2

CONTROLLER
Treats the underlying inflammation with
every inhalation*2
Mucus-producing
layer
- less inflamed
*Symbicort Maintenance and Reliever therapy 200/6 μg Turbuhaler doses only.
**SABA: short-acting β2-agonist.
References: 1. Kuna P et al. Int J Clin Pract 2007;61(5):725-736. 2. SymbicortR Turbuhaler 160/4.5, Inhalation powder. Summary of Product Characteristics. Saudi Arabia.
January 2018. 3. O’Byrne PM et al. Eur Respir J 2017;50:1701103. 4. Salamol Easi-Breathe. Summary of Product Characteristics. May 2018.
COMPASS: STUDY1

6-months randomized, double blind, double dummy study


Salmeterol/Fluticasone 50/250 μg +
Bricanyl as needed n=1123
Run-in Salmeterol/Fluticasone evohaler (PMDI) 125/25 2 inh. Bid =
500/100 μg daily

Regular ICS ≥
500 μg R Symbicort 320/9 μg 1 bid +
Bricanyl as needed n=1105

n=3335
Symbicort 160/4.5 μg 1 bid +
Symbicort as needed n=1107

Week: -2 0 8 16 24
Visit: 1 2 3 4 5

Reference: 1. Kuna P, Peters MJ, Manjra Al, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract. 2007; 1-12.
AHEAD STUDY

6-months double blind, multinational study

Run-in 1 inhalation Salmeterol/Fluticasone Diskus® 50/500μg bid +


Bricanyl turbuhaler 0.4mg as-needed n=1155
Regular ICS ≥
500 μg plus
LABA
R
2 inhalations Symbicort Turbuhaler® 160/4.5 μg bid +
Enrolled = 3346 Symbicort as needed n=1154
Randomized = 2309

Week: -2 0 4 13 26
Visit: 1 2 3 4 5

Randomisation

Reference: 1. Bousquet J, Boulet LP, Peters MJ, et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir
Med. 2007; 101: 2437-2446.
SYMBICORT® As-Needed Reliever with Maintenance
Is Superior in Reducing Exacerbations Against Other Maintenance Regimens

In moderate-to-severe asthma, SYMBICORT® reduced severe exacerbation rates by 21 to 48% vs. ICS-LABA maintenance. 1-4

OVER
10,000
PATIENTS

Severe exacerbation definitions are provided below as per different studies.


Rabe: Severe exacerbation was defined as an event resulting in hospitalisation, emergency room (ER) treatment, or both, or the need for oral steroids for 3 days or more.2 Kuna:
Severe exacerbation was defined as deterioration in asthma resulting in hospitalisation or ER treatment, or the need for oral steroids for ≥3 days.4 Bousquet: Severe exacerbation was
defined as deterioration in asthma leading to hospitalisation/ER treatment and/or oral corticosteroid treatment for at least 3 days.5

1. Rabe KF, Atienza T, Magyar P, et al. Lancet 2006;368:744–753. 2. Vogelmeier C, D’Urzo A, Pauwels R, et al. Eur Respir J 2005;26:819–828. 3. Kuna
P, Peters MJ, Manjra AI, et al. Int J Clin Pract 2007;61:725–736. 4. Bousquet J, Boulet LP, Peters MJ, et al. Respir Med 2007;101:2437–2446. 5.
Ventolin EvohalerR 100. Summary of Product Characteristics.
SYMBICORT® Delivers a Higher Proportion of Optimally
Sized Particles** vs. Other Competitors†1-4

• Optimally sized particles in the range of 1-5 μm are more likely to be deposited in the lungs than smaller or larger particles.1,2
• SYMBICORT® Turbuhaler® delivers 41.8% of its particles in the optimal range.1
Optimally sized particles (1-5 μm)
Based on an in vitro study evaluating 4 marketed ICS/LABA DPIs. 25

SYMBICORT® Turbuhaler® delivered a higher proportion of optimally sized particles (in the range of 1-5 μm)
compared with 3 other ICS/LABA DPIs.25,26

Foster® NEXThaler®1 Rolenium® Elpenhaler®1 Seretide® Diskus®1 SYMBICORT® Turbuhaler®1

26.5% 16.7% 22.1% 41.8%


These percentages relate to the ICS component of each DPI (in vitro).
The relationship between the pharmacological properties and clinical efficacy has not been established and there are also other variables that influence lung
deposition and distribution of a drug.
*SYMBICORT® Turbuhaler®.
**SYMBICORT® Turbuhaler® has optimal particle size distribution because particles in the aerodynamic size range from 1–5 μm are shown to be highly likely to be deposited in the lungs, as
particles <1.0 μm are very likely to be exhaled again while those >5 μm may impact on the oropharynx.
SYMBICORT® DPI particle size data are taken from in vitro studies. SYMBICORT® DPI mass median aerodynamic diameter (MMAD) = 2.07 μm.25,26

Foster® NEXThaler®, Rolenium® Elpenhaler®, Seretide® Diskus®.

References: 1. De Boer AH, et al. Eur J Pharm Biopharm 2015;96:14351. 2. Demoly P, et al. Respir Med 2014;108:1195-1203. 3. Hozawa S, Terada M, Hozawa M. Pulm
Pharmacol Ther 2011;24:571-576. 4. Hozawa S, Terada M, Hozawa M. Pulm Pharmacol Ther 2014;27:190-196.
GINA 2023
Adults & Adolescents 12+ Years

Disclaimer: - Budesonide/formoterol 160/4.5μg Maintenance and Reliever Therapy is approved in Kuwait, Bahrain, Qatar for adults and adolescents at GINA Steps (3-5) Only
- ICS/SABA is not approved in each of GCC Countries

HDM: house dust mite; ICS: inhaled corticosteroid; LABA: long-acting beta2-agonist; LAMA: long-acting muscarinic antagonist; LTRA: leukotriene receptor antagonist;
OCS: oral corticosteroids; SABA: short-acting beta2-agonist; SLIT: sublingual immunotherapy.
References: GINA Guidelines 2023, Box 3-12, p65.
GINA 2023 Treatment Recommendation1
Global Initiative for Asthma (GINA) Strategy 2023 - Treatment

Disclaimer: Budesonide/formoterol 160/4.5μg Maintenance and Reliever Therapy is approved in Kuwait, Bahrain, Qatar for adults and adolescents at GINA Steps (3-5) Only

AIR: Anti-Inflammatory Reliever; BDP: beclometasone-dipropionate; ICS: inhaled corticosteroid; MART: Maintenance And Reliever Therapy with ICS-formoterol;
SABA: short-acting beta2-agonist. *Doses are metered doses. See page 4 for corresponding delivered doses and for more details about medications and dosing.
Copyright © 2021 · All Rights Reserved · Global Initiative for Asthma - GINA
References: GINA Guidelines 2023, Box 3-8, p61.
GINA 2023 Treatment Recommendation1
Global Initiative for Asthma (GINA) Strategy 2023 - Treatment

Reference: GINA Guidelines 2023, Box 3-14, p67.


GINA 2023 Treatment Recommendation1
Global Initiative for Asthma (GINA) Strategy 2023 - Treatment

Disclaimer:
- Budesonide/formoterol 160/4.5μg Mild Asthma indication only approved in UAE and Oman

AIR: Anti-Inflammatory Reliever; BDP: beclometasone-dipropionate; ICS: inhaled corticosteroid; MART: Maintenance And Reliever Therapy with ICS-formoterol; SABA:
short-acting beta2-agonist. *Doses are metered doses. See page 4 for corresponding delivered doses and for more details about medications and dosing. Copyright © 2021 ·
All Rights Reserved · Global Initiative for Asthma – GINA
Reference: GINA Guidelines 2023, Box 3-15, p80.
SYMBICORT® Is an Anti-inflammatory Reliever That
Could Change the Lives of Asthma Patients

1
Across all
Severities is: A preferred reliever that SUPERIOR IN REDUCING ONLY ONE INHALER
WORKS AS FAST AS EXACERBATIONS, that keeps life simple
SABA to relieve both vs. SABA alone or and uses a patient's
Symptoms.1-4 SABA + ICS-LABA* natural relief-seeking
maintenance.5-8 behaviour.1

ICS-FORMOTEROL
RECOMMENDED BY GINA 2021

References: 1. SYMBICORT® Turbuhaler 160/4.5, Inhalation powder. Summary of Product Characteristics. 2. Seberova E and Andersson A. Respir Med 2000;94(6):607-611.
3. Ventolin EvohalerR 100. Summary of Product Characteristics. 4. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention.
2021. Available at: http://www.ginasthma.org/. 5. Rabe KF, Atienza T, Magyar P, et al. Lancet 2006;368:744–753. 6. Vogelmeier C, D’Urzo A, Pauwels R, et al. Eur
Respir J 2005;26:819-828. 7. Kuna P, Peters MJ, Manjra AI, et al. Int J Clin Pract 2007;61:725-736. 8. Bousquet J, Boulet LP, Peters MJ, et al. Respir Med
2007;101:2437-2446.
SYMBICORT DOSES

1 or 2 Inhalation 1 or 2
inhalation in the inhalation in the
morning2 AS NEEDED2 evening2

► Maintenance doses depends on severity level.2


► Symbicort can be used up to 8 inhalations/day.2
► A total daily dose of up to 12 doses/day could be used for a certain period.2
► Maximum inhalations per occasion are 6 inhalations. 2
BIOLOGICS

•Biologics are drugs that target a specific molecule, cell, or antibody that is causing a person’s asthma. Biologics
are given by an injection under the skin or as an infusion into a vein.

•Biologics are used for moderate to severe asthma that is not well controlled by other drugs. This includes
people who are regularly admitted to the hospital, use a rescue inhaler several times a day or week, or who are
taking oral steroids.

•There are several biologics for asthma, including:


 Xolair (omalizumab)
 Nucala (mepolizumab)
 Cinqair (reslizumab)
 Fasenra (benralizumab)
 Dupixent (dupilumab)
ALLERGY SHOTS AND UNDER-THE-TONGUE
ALLERGY TREATMENTS (IMMUNOTHERAPY)

•Immunotherapy for asthma includes allergy shots and under-the-tongue allergy


treatments. You start by taking a very small dose of an allergen. The dose increases
over time. A course of allergy shots can take 3 to 5 years. During that time, your
body builds up a tolerance to the allergen, making you less likely to react.

•Immunotherapy is most useful when there is a clear link between an allergen and
symptoms. It seems to work best to treat grass, cat, dust mite, and ragweed
allergies, and less well for cockroach and mold allergies.

•Allergy shots are given in a doctor’s office. Under-the-tongue allergy treatment is


taken in a doctor’s office the first time and at home after that.
TURBUHALER
The device that delivers
Turbuhaler Technology - Simple Outside,
Sophisticated Inside
Particle Size Range for Lung Deposition

Exhalation or Alveolar Deposition


Oropharyngeal Impaction Optimal Lung Deposition
and Systemic Absorption

<1 µm <1 µm <1 µm

1–5 µm 1–5 µm 1–5 µm


>5 µm >5 µm >5 µm

Particles >5 µm may hit the back of the throat and Particles 1-3 µm most likely deposited in central Particles <1 µm may be exhaled before they can
never reach the lungs. They impact the oropharynx and peripheral airways.1 reach the lungs, or they may be absorbed into
and are swallowed with potential systemic the bloodstream.1,2
effects.1,2

References: 1. de Boer AH et al. Eur J Pharm Biopharm. 2015;96:143-151; 2. Demoly P et al. Respir Med. 2014;108:1195-1203.
Critical Use Errors:
Shaking

In an in-vitro study
assessing the effect of
shaking or not shaking
prior to inhalation on
DD, only Turbuhaler
was largely unaffected
by shaking or not
shaking.1

Labeling guidance.
a

DD= delivered dose; DPI= dry powder inhaler.


Reference: 1. Janson C, et al. Pulm Ther. 2017;3:243-253.
Critical Use Errors:
Humidity Effect

Fine-particle dose for budesonide after storage at ambient


temperature and 75% relative humidity
• No significant decrease in either fine particle dose
(FPD) or delivered dose (DD) occurred with
Turbuhaler* over 6 months.1

• For the Easyhaler, FPD decreased by:


- 68% in BUD at 40o C (vs. 18% for Turbuhaler)
- 48% in FORM at 40o C
- 34% in BUD at ambient temperature**
- 20% in FORM at ambient temperature

• Turbuhaler has an inherent moisture protection,


as it contains a desiccant and has a tight cover
that screws tightly to the turning grip.

DPI aerosol performance has been studied in vitro after exposure to 75% humidity in both ambient and accelerated temperature over 6 months of storage.

* Single BUD inhaler /ambient temp.


** Observed already after 1.5 months of storage.
Reference: 1. Janson C, et al. NPJ Prim Care Respir Med 2016;26:16053.
SYMBICORT® Summary

SYMBICORT® RELVAR FOSTAIR EASYHALER


pMDI®4/FOSTAIR
TURBOHALER®1 ELLIPTA®2 NEXTHALER®5 BUFOMIX®7

Globally* preferred reliever with clinical


evidence as a reliever in a real-world setting.

Clinical evidence showing benefits vs.


stepping up the ICS-LABA dose.†

Inhaler that can be kept wherever the patient


wants with no storage restrictions.

Longest shelf-life once opened: 2 years 1 month 3/6 months 4 months


As a reliever no need to replace often.

This slide contains indirect comparison studies. Please note as H2H studies were not conducted between these treatments; they have been compared indirectly.

ICS= inhaled corticosteroids; LABA= long-acting beta-agonists; SABA= short-acting beta-agonists.


*GINA guidelines 2019.

H2H studies vs. higher and highest Seretide doses.

References: 1. Symbicort® Turbuhaler 200/6 [summary of product characteristics]. Luton: AstraZeneca UK Limited; 2018 [anticipated new licence]. 2. Relver Ellipta® 92/22
[Summary of Product Characteristics]. Ireland: GlaxoSmithKline Limited; 2019. 3. Seretide Accuhaler® 50/100 [Summary of Product Characteristics]. Middlesex :
GlaxoSmithKline UK Limited; 2018. 4. Fostair® 100/6 [Summary of Product Characteristics]. Manchester: Chiesi Limited; 2019. 5. Fostair NEXThaler® 100/6 [Summary of
Product Characteristics]. Manchester: Chiesi Limited; 2019. 6. DuoResp Spiromax® 320/9 [Summary of Product Characteristics]. Swensweg: Teva Pharma B.V, 2019 7.
Easyhaler Bufomix® 320/9 [Summary of Product Characteristics]. Orionintie 1: Orion Corporation; 2017.
SYMBICORT DOSES

1 or 2 Inhalation 1 or 2
inhalation in the inhalation in the
morning2 AS NEEDED2 evening2

► Maintenance doses depends on severity level.2


► Symbicort can be used up to 8 inhalations/day.2
► A total daily dose of up to 12 doses/day could be used for a certain period.2
► Maximum inhalations per occasion are 6 inhalations. 2
K 1 Not

AC approved

H TR
WIT
A RT
ST 1
AC K
O TR
H T
ITC
SW Document Number: AE-0723
Preparation Date: Jan, 2022
Expiry Date: Jan, 2024
Thank You
Confidentiality Notice
This file is private and may contain confidential and proprietary information.
If you have received this file in error, please notify us and remove it from your system
and note that you must not copy, distribute or take any action in reliance on it.
Any unauthorized use or disclosure of the contents of this file is not permitted and may
be unlawful. AstraZeneca PLC, 1 Francis Crick Avenue, Cambridge Biomedical Campus,
Cambridge, CB2 0AA, UK, T: +44(0)203 749 5000, www.astrazeneca.com

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