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3.2 Corticosteroids

3.2 Corticosteroids
          The preferred formulary choice of inhalers containing steroids for managing asthma and COPD with suitable  
          conversion options from a less desirable to a preferred inhaler can be found here. Further information is below.
          For asthma prophylaxis, must be used regularly. Clenil Modulite® or Qvar® are most economical when lower doses 
          are required and should be used first line.  See 'CFC-Free Beclometasone Inhalers' below.   
          Risks associated with high dose inhaled corticosteroid (ICS) 
          The risk of systemic adverse effects from ICS is dose related. For adults, low to moderate doses represent little or no risk  
          but, high-dose therapy has been directly linked to adverse effects such as skin thinning, bruising, osteoporosis, diabetes and 
          adrenal suppression. 
          Patients on high dose ICS should be reviewed regularly and provided with a steroid card.
          Approximately 85% of patients with asthma can be controlled on doses ≤800 micrograms/day of ICS
         Patients with COPD and with an FEV1 of less than or equal to 50% of predicted, and having two or more exacerbations per  
         year (requiring antibiotic or oral corticosteroid) should be offered prophylactic treatment with inhaled corticosteroid as a 
         combination with long acting therapy, and review at 8 weeks. 
         CFC-Free Beclometasone Inhalers 
         These two CFC-free products (QVAR® and Clenil Modulite®), both containing the active substance beclometasone 
         dipropionate are NOT equipotent and this could have safety implications.  When the prescriber wishes a patient to have a 
         CFC-free inhaler Pharmacists receiving a generic prescription for a beclometasone dipropionate pMDI must establish which 
         of the two available branded products should be dispensed. 
             1. Clenil Modulite® (Trinity-Chiesi Pharmaceuticals Limited) should be prescribed at the same dose as the CFC- 
                 containing beclometasone dipropionate pMDIs. 
             2. Qvar® (Ivax Pharmaceuticals Limited) has a 2 to 2.5 fold greater potency than the CFC-containing beclometasone  
                 diproprionate pMDIs and therefore should be prescribed at a lower dose than the CFC-containing beclomethasone 
                 dipropionate PDMIs.
                 Further information is available in the Summary of Product Characteristics. 
            3. Clenil Modulite® is authorised for use in children; Qvar® is not authorised for use in children (12 years of age 
                and younger). 
            4. For all inhaled corticosteroids and in line with accepted clinical practice, when control of asthma is achieved the dose of 
                the inhaled corticosteroid should be titrated to the lowest dose at which effective control of asthma is maintained.
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All NEW patients requiring a beclometasone inhaler, should be initiated on a CFC-free brand, either QVAR® or Clenil Modulite®.
The choice of brand used should be based on the dose required, the licensed indications, cost and cost effectiveness and the
inhaler types available. 
GREEN       Clenil Modulite® (beclometasone CFC-Free) metered dose inhaler (MDI) (able to used with a Volumatic® device)
                   50 microgram/inhalation,
                   100 microgram/inhalation 
                   200 microgram/inhalation
                   250 microgram/inhalation 
GREEN       Qvar® (beclometasone CFC-Free) metered dose inhaler (MDI)  (able to used with an Aerochamber® device).     
                   Metered dose inhaler (MDI) & Autohalers available   
                   50 microgram/inhalation
                   100 microgram/inhalation 
GREEN      Qvar® Easi-Breathe  (beclomethasone CFC free
                   breath actuated aerosol  inhalation 
                   50mcg/metered inhalation
                   100mcg/metered inhalation
Other Steroid Inhalers
When considering doses, beclometasone dipropionate (Clenil® brand) and budesonide are equipotent and fluticasone is twice as 
GREEN      Budesonide (Pulmicort®)  dry powder inhaler 
                  100 microgram/inhalation (Pulmicort Turbohaler 100® )    
                  200 microgram/inhalation (Pulmicort Turbohaler 200®)
                  400 microgram/inhalation (Pulmicort Turbohaler 400®)
GREEN      Fluticasone (only recommended when high dose therapy is required)
                  Metered dose inhaler 
                  125microgram/inhalation, 250microgram/inhalation  
                  Dry powder inhaler
                  50microgram/inhalation (Flixotide 50 Accuhaler®)
                  100microgram/inhalation (Flixotide 100 Accuhaler®)  
                  250microgram/inhalation (Flixotide 250 Accuhaler®)
AMBER     Ciclesonide inhaler 80microgram /inhalation,160mcg/inhalation (Alvesco® inhaler)
                   [Treatment option in asthma where exacerbations continue despite other step 4 therapies, secondary care initiation]
Treatment of Bronchopulmonary Dysplasia (BPD): Croup and acute asthma in paediatric patients
AMBER     Budesonide nebules 1mg/2mL, 0.5mg/2mL (paediatric specialist use only)
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Compound preparations containing corticosteroids
If patients remain symptomatic on monotherapy, their treatment should be intensified by combining therapies from different drug
classes. Combination of long-acting beta2-agonist plus inhaled steroid is a treatment option. The clinical effectiveness of combined
treatments can be assessed by improvements in symptoms, activities of daily living, exercise capacity and lung function.
Combination treatment should be discontinued if there is no benefit after 4 weeks.  
DuoResp® Spiromax®, Fobumix Easyhaler® and Symbicort® Tubohaler contain budesonide/formoterol. 
There are 2 strengths of DuoResp® Spiromax and Fobumix Easyhaler®  160/4.5, and 320/9. These are equivalent to Symbicort 200/6
and Symbicort 400/12 respectively. 
Although equivalent the inhaler devices are significantly different. Resultantly it is important to specify theinhaler by brand when
prescribing in order to ensure patients receive a device they are familiar with.
GREEN    DuoResp® Spiromax 160/4.5
                 equivalent to Formoterol 6micrograms/inhalation + budesonide 200micrograms/inhalation 
                 (dose= 1-2 puffs twice daily, max 4 puffs twice daily)  
GREEN    DuoResp® Spiromax 320/9   
                 equivalent to Formoterol 12micrograms/inhalation + budesonide 400micrograms/inhalation
                 (dose= 1 puff twice daily, max 2 puffs twice daily) 
GREEN    Symbicort Turbohaler® 100/6,200/6  Formoterol 6micrograms/inhalation + budesonide
                 (dose= 1-2 puffs twice daily, max 4 puffs twice daily) 
GREEN    Symbicort Turbohaler® 400/12 (Formoterol 12micrograms/inhalation +  budesonide 400) 
                 (dose= 1puff twice daily, max 2 puffs twice daily)   
GREEN    Fobumix Easyhaler® 160/4.5 (equivalent to Budesonide 200micrograms + Formoterol 6 mcg/inhalation)
                (dose = 2 puffs twice daily, max 4 puffs twice daily)
GREEN    Fobumix Easyhaler® 320/9 (equivalent to Budesonide 400micrograms + Formoterol 12 mcg/inhalation)
                 (dose = 2 puffs twice daily, max 2 puffs twice daily) dose for COPD is 1 puff twice a day
GREEN    Trelegy Ellipta® (Umeclidinium+Vilanterol+Fluticasone)

                (dose = 1 puff daily)

AMBER  Anoro Ellipta® Umeclidinium bromide 65micrograms + Vilanterol 22micrograms/dose dry powder inhaler
               (dose = 1 inhalation daily) [specialist initiation]
2nd line treatment in asthma pathway, secondary care initiation only
AMBER    Relvar Ellipta® 92 micrograms/22 micrograms/dose  [Futicasone with vilanterol] dry powder inhaler
                 Relvar Ellipta® 184 micrograms/22 micrograms/dose  [Futicasone with vilanterol] dry powder inhaler
                 [dose = 1 inhalation daily]
GREEN     Atectura Breezhaler 125/127.5 inhalation powder, hard capsules 
                 [150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate]
                 Atectura Breezhaler 125/260 inhalation powder, hard capsules
                 [150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate]
                 Atectura Breezhaler 125/62.5 inhalation powder, hard capsules
                  [150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate]
                  [dose = 1 inhalation daily]
GREEN    Enerzair® Breezhaler® inhalation powder, hard capsules
restricted [150 mcg of indacaterol (as acetate), 63 mcg of glycopyrronium bromide equivalent to 50 mcg of glycopyrronium and 
                   160 mcg of mometasone furoate]
                   [dose = 1 inhalation daily]
                  Suitable for prescribing in primary care following recommendation or initiation by a specialist
Trimbow® inhaler  - link to guideline
First line use in Patient Group D, where patient requires Triple Therapy (LAMA+LABA+ICS)
(single combination inhaler, dose 2 puffs bd)
GREEN   Beclomethasone 87mcg, formoterol fumarate 5mcg,  
                glycopyrronium bromide 9mcg   (Trimbow®pMDI)

Note: Of the Symbicort® range, both the 200/6 and 400/12 strengths are licensed for use in COPD as are the DuoResp Spiromax.
Symbicort® SMART, DuoResp Spiromax maintenance and reliever therapy and Fostair® MARTregime for asthma 
Symbicort® and DuoResp Spiromax inhalers contain the inhaled steroid budesonide and the long action beta-2 agonist formoterol 
whilst Fostair contains ultra fine beclomethasone and formoterol. Although long acting formoterol has a quick onset of action
allowing it to be used to relieve symptoms when required..The use of Symbicort® 100/6 or 200/6 used as a rescue medication 
instead of a short acting beta-2 agonist such as salbutamol in addition to its regular use as a controller therapy has been shown to
be an effective treatment regimen. In line with updated BTS Guidance, Symbicort® SMART regimen for use in asthma in adults is 
approved within the following restrictions: 
          >     In selected adult patients at step 3 of the BTS/NICE guidelines who are poorly controlled, or in selected adult patients at 
                 step 2 (above beclometasone 400micrograms/day who are poorly controlled),
          >     Patients taking rescue Symbicort® once a day or more should have their treatment reviewed,
          >     Careful patient selection and education of patients about the specific issues around this management strategy is 
Only the 100/6 and 200/6 strengths should be used as part of this regimen. The 400/12 strength of Symbicort® should not be 
used in this way.
DuoResp Spiromax maintenance and reliever therapy- Only the 160/4.5microgram strength should be used as part of this
Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to
symptoms. Patients should be advised to always have DuoResp Spiromax available for rescue use. DuoResp Spiromax maintenance
and reliever therapy should especially be considered for patients with: 
     >       inadequate asthma control and in frequent need of a reliever inhaler.
     >       asthma exacerbations in the past requiring medical intervention.
Recommended doses: 
Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the 
morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations 
twice daily may be appropriate. Patients should take 1 additional 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 
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 strongly recommended to seek medical advice. 
They should be reassessed and their maintenance therapy should be reconsidered.

Fostair® may also be used as maintenance and reliever therapy (MART) It  is currently recommended as an option for the 
management of asthma in adults in line with BTS guidance. This product is not licensed for use in children or adolescents
under the age of 18 years.
(Fostair 100/6 MDI 1 puff twice a day plus extra puffs as required max 8 puffs daily)
Again careful patient selection and education about the specific issues around this management strategy is required.
GREEN       Beclometasone + formoterol 100micrograms/6micrograms per inhalation 
                    (metered dose inhaler (Fostair® 100/6 or Fostair NEXThaler) 
                    (dose= 1-2 puffs twice daily, max 4 puffs daily unless being used as MART therapy discussed above)
GREEN       Beclometasone + formoterol 200micrograms/6micrograms per inhalation
                   (metered dose inhaler (Fostair® 200/6) 
                   (dose= 2 puffs twice daily)
Please note Fostair requires storage in a fridge prior to dispensing, and has an expiry of 5 months after dispensing to the patient 
(who should then keep the inhaler at room temperature). Note it contains a small amount of alcohol in the formulation.
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Fluticasone/Salmeterol inhalers
These are currently not included in the ELMMB Asthma and COPD guidelines for adults over 18 years of age.
There are now more than one product containing the combination of fluticasone/salmeterol.
These are AirFlusal®, Sereflo®, Fospiro , Sirdupla® and Seretide.  Whilst these products are clinically equivalent, the devices differ. In order to 
prevent confusion to patients such combination inhalers should be prescribed by brand. 
When Fostair®  or Duoresp®  are not suitable or the patient wishes to remain on Fluticasone then AirFlusal® Fospiro is the preferred
product of choice. 
For 12-18 year olds at Step 3 of the asthma guidelines who cannot use Symbicort Turbohaler, Fostair, Sirdupla or AirFluSal are not 
licensed. The alternative choice therefore is Seretide 50 MDI 2puffs BD at Step 3a and Seretide 125 2 puffs BD at Step 3b.
GREEN           Salmeterol 25micrograms/inhalation + fluticasone
                        (dose=2 puffs twice daily)   
                        Metered dose inhaler:
                        (AirFluSal® 25/125mcg MDI/ 25/250mcg MDI - preferred choice) 
                        (Sirdupla® inhaler or Seretide Evohaler® 125, 250 Seretide Evohaler® 50)  
GREEN           Salmeterol 50micrograms/blister + fluticasone 
                        (dose=1 blister twice daily)     
                       Dry powder inhaler  AirFluSal®Forspiro (preferred choice) 
                                                            Seretide Accuhaler® 100, 250, 500   
Please note the difference in dosing between: 
                       >   Metered dose inhalers (2 puffs twice daily) and 
                       >   Accuhalers®/DPI One blister twice daily). 
NOTE: Of the Seretide® range, only the Seretide® Accuhaler 500 is licensed for use in COPD. 
Neither the Seretide® Evohaler nor the Accuhaler® strengths are licensed for use in COPD.  

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