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SYMBICORT® (budesonide/formoterol) Reliever Therapy | AstraZeneca UK
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Symbicort® 
Reliever Therapy (Turbohaler® 200/6)

Imagine if the inhaler you prescribe to your mild asthma patients could relieve symptoms and reduce future asthma attacks at the same time?

Symbicort® Reliever Therapy (Turbohaler® 200/6) can be prescribed as a reliever therapy for adults and adolescents 12 years and older with mild asthma, giving them relief of their asthma symptoms while at the same time delivering a small amount of steroid to treat their inflammation.1

For more information on other Symbicort® indications click here.

What is Symbicort® Reliever Therapy (Turbohaler® 200/6)

Prescribing information and Adverse Event Reporting can be found at the top and bottom of this page

Watch Dr Tom Brown (Respiratory Specialist) introducing Symbicort® Reliever Therapy (Turbohaler® 200/6).

How to prescribe Symbicort® Reliever Therapy (Turbohaler® 200/6): asthma review demonstration

Prescribing information and Adverse Event Reporting can be found at the top and bottom of this page

Watch how Jo Hamilton, a Lead Respiratory Nurse from Dudley in the West Midlands, reviews patients to optimise their treatment.

 

Symbicort® Turbohaler® 200/6 is indicated as reliever therapy for adults and adolescents ≥12 years with mild asthma.1 For further information, maximum dosage and method of administration for Symbicort® Turbohaler® 200/6, click here.

Explore profiles of the patients that might be suitable for Symbicort® Reliever Therapy (Turbohaler® 200/6)

  • She continues with sports despite feeling breathless at times, however, her parents are concerned
  • Her wheezing is worse at night and in the evenings, and sometimes in the mornings
  • She is affected by seasonal changes like cold weather and hay fever
  • She doesn’t think she has asthma; her parents want to double check

Based on Sam’s symptoms, you suspect she may have mild asthma

How could you help Sam* get the fast symptom relief she wants and the exacerbation protection she needs?

adolescent_fictional_patient

*Please note that Sam is a fictional patient and case study

Diagnosis: mild asthma
Prescribed treatment: ICS (brown inhaler) +
SABA (blue inhaler) as needed

  • She has been using her SABA four or five times a week for symptom relief
  • She does not use her ICS regularly, only when she feels wheezy during seasonal changes
  • She mistakenly considers her asthma to be "very mild, doesn't impact my life" and missed her recent asthma reviews

How could you help Toni* get the fast symptom relief she wants and the exacerbation protection she needs?

adult_fictional_patient

*Please note that Tony is a fictional patient and case study

 

How to prescribe Symbicort® Reliever Therapy (Turbohaler® 200/6)
Find Symbicort® Reliever Therapy (Turbohaler® 200/6) materials to support your patients

Reduce SABA over-reliance in your practice

Asthma is an inflammatory and variable disease and if the inflammation is left untreated it could increase the frequency and/or severity of asthma symptoms. This could lead to an asthma attack requiring emergency treatment and/or hospitalisation.2-4

SABA inhalers treat asthma symptoms but do not treat the inflammation and your patients could become over-reliant† on their SABA inhalers.5

 

Studies show patients taking 3 or more SABA inhalers a year (compared to 0-2 SABA inhalers) are twice as likely to have an asthma attack^ irrespective of the severity of their asthma.5

Symbicort® Reliever Therapy (Turbohaler® 200/6) delivers a low dose of steroid to treat airway inflammation.1 It also contains formoterol which works as fast as SABA (onset of effect within 1-3 minutes) when your patient seeks symptom relief as needed.1,6,7


Inhaler carbon footprint

green-plant

Over-relying† on SABA inhalers is not only a potential issue for your patients.
The use of SABA inhalers also contributes to the UK’s total inhaler carbon footprint, of which 70% of this footprint comes from SABAs with 83% of SABAs prescribed are to patients using more than three inhalers a year.8,9

†Over-reliance is defined as ≥3 inhalers/year (pMDI and DPI). This figure is extracted from the SABINA UK study9 and extrapolated to the UK adult asthma population.
^Defined as either asthma worsening that necessitated a short course of OCS (≤300mg; not during an annual asthma review or on days treated for other steroid responsive diseases - GP managed exacerbation), an Accident and Emergency (A&E) department visit for asthma, a hospital admission or death secondary to asthma.

 

Simplicity - Preventer and reliever in ONE inhaler

Patients want fast relief from their symptoms and tend to continue with medication regimes they already know when symptoms occur – including increasing their use of SABA.10

 

Symbicort® Reliever Therapy (Turbohaler® 200/6) is SABA-free combining both a preventer and reliever in one inhaler.1 It’s taken as needed to give patients the symptom relief they seek while reducing underlying inflammation.1

 

If your patients' asthma treatment needs to be stepped up or down, Symbicort® Reliever Therapy (Turbohaler® 200/6) can be titrated as a continuum of inhaled therapy in line with their HCP consultation and agreed personal asthma action plan.1

MoA_image MoA_image

Dosing

When Symbicort® Reliever Therapy (Turbohaler® 200/6) is taken as a reliever, patients should take 1 inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.1

If a patient finds the treatment less effective or experiences progressive deterioration of symptoms despite taking Symbicort® as needed, the patient should seek medical attention as soon as possible (see section 4.4 of the Symbicort® Turbohaler® 200/6 SmPC for further information).1

A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be reassessed for alternative explanations of persisting symptoms. Patients should be assessed at regular intervals according to local practice to determine whether their as-needed treatment with Symbicort® remains optimal or whether regular scheduled treatment with inhaled corticosteroid-containing maintenance medication should be initiated.1

For more information on Symbicort® Turbohaler® 200/6 please see SmPC

Efficacy data

For full information on the efficacy data supporting Symbicort® Reliever Therapy (Turbohaler® 200/6) please consult the SmPC.

SYGMA 1: Symbicort® Given As Needed in Mild Asthma11

SYGMA 1 O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide–formoterol as-needed in mild asthma. N Engl J Med 2018;378:1865–1876

SYGMA 1 was a 52-week, Phase III, multicentre, randomised, double-blind, parallel-group study that compared as-needed budesonide/formoterol with as-needed terbutaline and maintenance budesonide plus as-needed terbutaline in 3836 patients with mild asthma.

Design: 3836 patients aged 12 years and older with a clinical diagnosis of asthma for 6 months or more and with confirmation of bronchodilator reversibility were enrolled in the study.

Patients were randomized to 1 of the following treatments:

  • Placebo BID + as-needed budesonide/formoterol 200/6 mcg (metered dose)
  • Placebo BID + as-needed terbutaline 0.5 mg (metered dose)
  • Budesonide 200 mcg (metered dose) BID + as-needed terbutaline 0.5 mg

Objective: To investigate the long-term efficacy and safety of as-needed budesonide/formoterol dry powder inhaler (DPI) compared with as-needed terbutaline and maintenance budesonide.

Results:

  • As-needed budesonide/formoterol was superior to as-needed terbutaline, significantly (P=0.046) increasing the odds of patients having a well-controlled asthma week by 14% (primary endpoint) (mean percentage per patient: 34.4% vs. 31.1%; ARI 3.3% weeks per patient; OR, 1.14; 95% CI: 1.00 to 1.30; P=0.046.) according to data collected via electronic diary. As-needed budesonide/formoterol was inferior to the maintenance budesonide group in terms of percentage of electronically recorded well-controlled asthma weeks per patient (secondary endpoint).
  • As-needed budesonide/formoterol significantly decreased the severe asthma exacerbation rate by 64% (ARR:0.13; annualised exacerbation rate:0.07 vs. 0.20; Rate Ratio: 0.36; 95% CI: 0.27 to 0.49; P<0.001) vs. as-needed terbutaline. Asthma exacerbation rates between as-needed budesonide/formoterol and the maintenance budesonide group were not significantly different (ARR: 0.02).
  • The median daily metered inhaled corticosteroid (ICS) dose required with as-needed budesonide/formoterol (57 mcg) was 83% lower than that required with the maintenance budesonide group (340 mcg)
  • The percentages of patients taking more than 8 or more than 12 inhalations of as-needed medication in 1 day on at least 1 occasion were greater with as-needed terbutaline than with as-needed budesonide/formoterol and maintenance budesonide
  • The most common adverse events (AEs) were upper respiratory tract infection, asthma, pharyngitis, bronchitis, headache, and allergic rhinitis
  • 52-week, double-blind, randomised, multicentre, controlled trial
  • 3,836 patients previously treated only with SABA as needed
  • An electronic diary ensured adherence

 

competitor_analysis_image1 competitor_analysis_image1

Primary endpoint was to investigate the superiority of as-needed Symbicort® Reliever Therapy versus as-needed terbutaline alone in terms of asthma symptom control, measured as weeks with well-controlled asthma.

Secondary endpoints included comparing as-needed Symbicort® Reliever Therapy versus as-needed terbutaline alone and versus budesonide maintenance

+ terbutaline in rates and time to the first severe exacerbation.

^measure: electronically captured well controlled asthma weeks (eWCAW)

*Severe exacerbation was defined as worsening asthma leading to systemic glucocorticoid treatment for ≥3 days, hospitalisation or emergency room visit leading to systemic glucocorticoid treatment; moderate–severe exacerbation was defined as including worsening asthma requiring addition of twice-daily inhaled budesonide 200 μg to avoid progression to a severe exacerbation11

Is Symbicort® Reliever Therapy (Turbohaler® 200/6) appropriate for mild patients in the real world? NOVEL START study

NOVEL START 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

Novel START was a 52-week, multicentre, randomised, open-label study that compared as needed budesonide/formoterol dry powder inhaler (DPI) as an anti-inflammatory reliever with as-needed salbutamol* and with maintenance budesonide plus as-needed salbutamol* in patients with mild asthma.

Design: 675 patients aged 18 years and older with a self-reported diagnosis of asthma (from a physician) were enrolled in the study. Patients were included if they had used SABA as their sole asthma therapy in the previous 3 months, on at least 2 occasions in the previous 4 weeks, but no more than 2 occasions per day, on average, in the previous 4 weeks.

The patients were randomised to one of the following treatments:

  • As-needed budesonide/formoterol DPI 200/6 mcg (metered dose) x 1 inhalation (n=220)
  • As-needed salbutamol* pressurized metered-dose inhaler (pMDI) 100 mcg x 2 inhalations (n=223)
  • Budesonide DPI 200 mcg (metered dose) x 1 inhalation BID + as-needed salbutamol pMDI 100 mcg x 2 inhalations (n=225)

 

Objective: To investigate budesonide/formoterol reliever therapy used on an as-needed basis among adults with mild asthma who had been treated previously with only as-needed short-acting β2-agonist (SABA).

Results:

  • As-needed budesonide/formoterol significantly reduced the annualised rate of asthma exacerbations (primary endpoint) by 51% (ARR: 0.205) compared to as-needed salbutamol (p<0.001), and it was associated with a similar rate of asthma exacerbations compared to maintenance budesonide (ARI: 0.020).
  • As-needed budesonide/formoterol showed a 60% reduction (ARR: 6.2%) in the number of severe exacerbations vs. as-needed salbutamol* and a 56% reduction (ARR: 5.2%) in the number of severe exacerbations vs. budesonide maintenance.
  • The mean daily metered inhaled corticosteroid (ICS) dose required with as-needed budesonide/formoterol (107±109 μg) was 52% lower than that required with the budesonide maintenance group (222±113 μg).
  • The most common adverse events (AEs) were upper respiratory tract infection, nasopharyngitis, asthma, influenza, and lower respiratory tract infection.
  • *In the study, salbutamol was referred to as 'albuterol', which is its US non-proprietary name.
  • 52-week, randomised, open-label, multicentre, parallel-group, controlled, Phase 3 study
  • 675 asthmatic adult patients previously treated only with SABA as needed

 

 

competitor_analysis_image2competitor_analysis_image2

Primary endpoint was the annualized rate of asthma exacerbations per patient
Secondary endpoint was the number of severe exacerbations

 

^An exacerbation was defined as worsening asthma that resulted in one or more of the following: an urgent medical care consultation (e.g., a primary care visit, an emergency department [ED] visit, or hospital admission); a prescription of systemic glucocorticoids for any duration; or an episode of high beta2-agonist use, which was defined as more than 16 actuations of salbutamol** or more than 8 actuations of Symbicort® over the course of 24 hours12

*Severe exacerbation was defined as worsening asthma leading to systemic glucocorticoid treatment for ≥3 days, hospitalisation or emergency room visit leading to systemic glucocorticoid treatment.

**In the study, salbutamol was referred to as ‘albuterol’, which is its US non-proprietary name.

 

Symbicort® (Turbohaler® 100/6 and 200/6 doses only) MART regimen
Discover resources for you 
and your patients
Click here for Symbicort® drug interactions, side effects 
and safety profile.

CI, confidence interval; BID, twice daily; OR, odds ratio; DPI, dry-powder inhaler; eWCAW, electronically captured well controlled asthma weeks; HCP, healthcare professional; ICS, inhaled corticosteroids; LABA, long-acting β2 adrenoceptor agonists; OCS, oral corticosteroids; pMDI, pressurised metered-dose inhaler; RR, relative rate; SABA, short-acting β2 antagonist; ARR, absolute risk reduction; ARI, absolute risk increase; SmPC, Summary of Product Characteristics.

 

  1. Symbicort® Turbohaler® 200/6, Inhalation powder. Summary of Product Characteristics.
  2. Global Initiative for Asthma. 2023 GINA Report, Global Strategy for Asthma Management and Prevention. http://www.ginasthma.org. [Accessed Mar 2024].
  3. Papi A, et al. Lancet 2018;391(10122):783-800.
  4. Kuna P, et al. Int J Clin Pract 2007;61(5):725-736. doi:10.1111/j.1742-1241.2007.01338.
  5. Bloom C et al. Adv Ther 2020; doi.org/10.1007/s12325-020-01444-5.
  6. Seberová E & Andersson A. Respir Med 2000;94(6):607-611.
  7. Ventolin (salbutamol) Evohaler 100 Summary of Product Characteristics. December 2019.
  8. PrescQIPP Community Interest Company. Inhaler carbon footprint. 2021. Available at: https://www.prescqipp.info/umbraco/surface/authorisedmediasurface/index?url=%2fmedia%2f5721%2f295i-inhaler-carbon-footprint-22.pdf [Accessed Mar 2024].
  9. Wilkinson AJK et al. BTS Oral Abstract No: S26. Available from http://dx.doi.org/10.1136/thorax-2020-BTSabstracts.32. [Accessed Mar 2024].
  10. Patridge MR et al. BMC Pulm Med 2006;6:13.
  11. O’Byrne PM, FitzGerald JM, Bateman ED, et al. Inhaled combined budesonide–formoterol as-needed in mild asthma. N Engl J Med 2018;378:1865–1876.
  12. Beasley R, et al. Controlled trial of budesonide–formoterol as-needed for mild asthma. N Engl J Med 2019;380:2020–2030.
  13. AstraZeneca UK Ltd. Data on File. ID: REF-189348 June 2023
  14. AstraZeneca UK Ltd. Data on File. ID: REF-217029 February 2024

GB-56713 | DOP: December 2024

 

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