Data extracted : 24/11/2017
 Formulary Section 3: Respiratory system
03.01 Bronchodilators
03.01 Asthma and COPD


  • Initial treatment of acute severe asthma should usually include oxygen, corticosteroid and high dose beta2 agonist via nebuliser or spacer.

  • Nebulised ipratropium bromide (Atrovent) should not be routinely added to the beta2 agonist. It is appropriate where life-threatening features are present or in those with poor response to initial therapy, when it may provide additional bronchodilator effect.

  • Although first line choice drugs have been indicated where possible, for any inhaled treatment choosing the most suitable device for the patient is an important factor for ensuring effective treatment.

  • Beta-blockers (including eye drops) are contra-indicated in patients with asthma.


  • Smoking cessation will reduce decline in lung function in COPD
Link   Sign Guidance: Asthma 2008 (updated Jan 2012)
03.01 Chronic obstructive pulmonary disease
03.01.01 Adrenoceptor agonists Selective Beta2 agonists
Link   Inhaler Device Technique and Product Guide
Link   Leicestershire Guidelines: Asthma - Adult Guidelines Short-acting beta2 agonists

  • Inhaled short-acting selective beta2 agonists are the treatment of choice for the relief of acute symptoms. Both salbutamol and terbutaline act within 3-5 minutes of inhalation. Oral therapy is rarely indicated and is no longer routinely recommended.

  • Successful inhalation therapy depends on selection of an appropriate device and good adherence (compliance). Current BTS/SIGN guidelines recommend a metered-dose inhaler (MDI) as first choice, but a significant number of patients find these difficult to use properly.  Many modern dry powder inhalers provide a cost effective and convenient alternative and are much easier to use.  If an MDI is prescribed it is essential to ensure that MDI technique is satisfactory and if not optimal a spacer must be used.

  • Spacer devices are an effective way of improving the delivery of drug from an MDI. The size of the spacer is important. The large volume spacers with a one-way valve (e.g. Volumatic) are the most effective but are often inconvenient for patients to carry. They also require  monthly washing  and “drip-drying”. Ensure that the MDI is compatible with the spacer device.

  • In acute severe asthma or exacerbation of chronic obstructive pulmonary disease administration of normal doses of beta2 agonist by MDI may not be adequate. High dose therapy should ideally be inhaled via a spacer (10-20 puffs taken separately) or nebuliser but can be given by injection if necessary (side effects are more likely).

  • Home nebuliser therapy is rarely indicated as MDI and spacer are equally effective. Only use when shown to be clearly beneficial by objective testing. Local Nebuliser guidance available via link below.

  • Methotrexate use for severe refractory asthma is classified as RED on the traffic light system for use by respiratory specialists only
Link   Leicestershire Guidelines: Nebuliser Guidance - for Adults with Asthma or COPD
Link   Leicestershire Guidelines: Stable COPD
Link   NICE CG 101: Chronic obstructive pulmonary disease (partial update June 2010)
First Choice:
Salbutamol  (Easyhaler®)
Salbutamol Easyhaler (DPI) should be used in patients on other DPIs
First Choice:
Salbutamol (MDI) 
Salbutamol MDI should be used in patients on other MDIs
Second Choice:
Terbutaline Sulphate  (Turbohaler®)
Second choice, for those who cannot tolerate salbutamol. Similar efficacy to salbutamol but a more expensive option. Long-acting beta2 agonists

  • In asthma long acting beta2 agonists (LABA) can be used for long term use to improve symptom control in patients who remain poorly controlled on inhaled steroids (Step 3 of the BTS Guideline) They should be used in addition to inhaled steroid therapy and not replace it. 

  • Formoterol has a more rapid onset of action than salmeterol and is also licensed for short-term symptom relief.

  • Formoterol MDI may be considered in those patients who are already using an MDI effectively and in whom adding an Easyhaler would compromise compliance. This is a more costly option.

  • Some generic salmeterol inhalers are not suitable for patients with soya or peanut allergies.  It would be prudent to switch to the formulary choice, formoterol, in those patients.    
First Choice:
Formoterol  (Easyhaler®)
Dry Powder Inhaler (DPI)
In asthmatics, formoterol should only be prescribed as part of a combination device (ICS/LABA), and a formoterol single agent inhaler should only be used in the few patients who require ciclesonide as an ICS.
For COPD patients, formoterol can be used as a single agent as long as there is no co-existing asthma.
Second Choice:
Formoterol  (Turbohaler®)
Dry Powder Inhaler (DPI)
Alternative device but more costly.
03.01.02 Antimuscarinic bronchodilators

  • Ipratropium is especially useful in chronic obstructive pulmonary disease.

  • Do not prescribe tiotropium with short acting antimuscarinic bronchodilators

  • Ipratropium nebuliser solution is relatively expensive. It should not be given routinely to hospital inpatients with acute asthma but may be added to treatment if a short-acting beta2 agonist alone proves insufficient. If used, review frequently and discontinue as soon as possible.

  • Nebulised ipratropium must only be administered via a mouthpiece and NOT a facial mask due to the risk of precipitating glaucoma.
Link   Leicestershire Guidance: LAMA Prescribing Aid For COPD
Link   Leicestershire Guidelines: Stable COPD
Restricted Drug  Aclidinium / Formoterol   (Duaklir Genuair®)
Dry Powder Inhaler (DPI)
COPD. LAMA /LABA combination for use in line with local guidance only
Restricted Drug  Tiotropium / Oldaterol   (Spiolto Respimat®)
Metered Dose Inhaler (MDI)
COPD. LAMA /LABA combination for use in line with local guidance only
03.01.02 Short Acting Anti-muscarinic Bronchodilators
Ipratropium Bromide (MDI) 
03.01.02 Long Acting Anti-muscarinic Bronchodilators
Tiotropium  (Respimat®)
Metered Dose Inhaler (MDI)

’Amber Simple amber for Asthma

’Green For COPD patients in line with Leicestershire prescribing aid
Tiotropium  (Braltus Zonda®)
For COPD patients in line with Leicestershire prescribing aid. Not licensed for use in asthma
Aclidinium Bromide   (Eklira Genuair®)
Dry Powder inhaler (DPI)
For patients who cannot manage the tiotropium device and in patients with renal impairment (as per Leicestershire Guidance )
Restricted Drug  Tiotropium  (Handihaler®)
For COPD patients.
’RestrictedIn UHL restricted to initiation by respiratory physicians.
03.01.03 Theophylline
  • Different brands of oral theophylline/aminophylline may not be bioequivalent. Patients should not change brands once stabilised unless plasma level monitoring is carried out. The brand name should always appear on prescriptions and in correspondence.
  • Theophylline and its salt aminophylline can produce bronchodilatation additional to that of the beta2 agonists. Slow release preparations of theophylline are better tolerated than standard formulations. They are effective for up to 12 hours and can be useful for nocturnal symptoms if given in adequate dosage.
  • Theophylline interacts with a number of other drugs with a risk of toxicity if co-prescribed with drugs inhibiting metabolism e.g. erythromycin, ciprofloxacin. Metabolism may be affected by cigarette smoking in some patients.
  • Monitoring of plasma levels of theophylline is not routinely necessary in stable patients but may be warranted in certain circumstances e.g. change in clinical status, where toxicity is suspected or during concomitant use of interacting drugs. Seek advice if unsure.
First Choice:
Theophylline  (Uniphyllin Continus®)
Oral slow release tablets.
First Choice:
Intravenous use for severe bronchospasm, which has not responded to nebulised salbutamol in asthma or chronic obstructive pulmonary disease (COPD).
IV Monograph available through ’Injectable Medicines Guide’ link on front page of INsite.
Second Choice:
Theophylline  (Slo-Phyllin®)
Oral slow release capsules.
03.01.05 Peak flow meters, inhaler devices and nebulisers
Selecting an inhaler device:
  • Inhalers should only be prescribed after patients have received training in use of the device and have demonstrated satisfactory technique. Metered-dose inhalers (MDIs) are an appropriate first choice but great attention is required to ensure the patient can use them correctly.
  • Spacer devices can help some patients who experience difficulty using an MDI; they also reduce adverse effects from inhaled corticosteroids. Less portable.
  • Breath-actuated devices (including dry powder inhalers) are an alternative to an MDI with a spacer.
  • Patients should be asked to demonstrate their inhaler technique at every opportunity. Hospital and community pharmacists can demonstrate inhaler devices and check inhaler technique if required.

  • CFC- Free Inhalers

  • Chlorofluorocarbon (CFC) containing beclometasone inhalers are being phased out during 2008. Patients should be switched to CFC alternatives now. Advice for prescribers on how to do this and product choices available via link below.
Link   Leicestershire Guidelines: Nebuliser
Link   NICE TA 10: Asthma (children under 5) - inhaler devices
Link   NICE TA 38: Asthma (older children) - inhaler devices
03.02 Corticosteroids

  • Inhaled corticosteroids act to reduce inflammation and consequent airway oedema and mucus secretion. They are therefore more effective in asthma than COPD.

  • Use a spacer device (e.g. Volumatic) for all patients on an MDI. This improves delivery of drug to the airways and reduces deposition in the oropharynx. Also reduces the need for co-ordinated inhaler technique and may help to reduce the incidence of candidiasis.

  • Nebulised steroids are inappropriate.

  • In the few patients requiring more than 800microg daily of beclometasone (400microg daily of Qvar®) budesonide is preferred due to less potential for systemic side effects (first pass metabolism of swallowed portion).

  • See also supporting information on Asthma, COPD and Combination inhalers.

  • Ciclesonide is occasionally used by specialists second line to other steroid inhalers in patients unable to tolerate due to thrush despite mouth rinsing and use of a spacer device. In UHL this has been restricted to Respiratory Medicine only.

  • Fluticasone inhalers are occasionally used by specialists in difficult to treat asthma. In UHL this has been restricted to Respiratory Medicine only. 

Link   Leicestershire Guidelines: Stable COPD
Link   NICE CG 101: Chronic obstructive pulmonary disease
Link   NICE TA 131: Asthma (in children) - corticosteroids
Link   NICE TA 138: Asthma (in adults) - corticosteroids
First Choice:
Beclometasone Dipropionate  (Qvar®)
For asthma in over 12 year olds (Use Clenil in children). Markedly better lung deposition and dose is equivalent to approximately twice the dose of CFC–containing inhalers or Clenil. Prescribe by brand.
First Choice:
Budesonide  (Budesonide Easyhaler® or Pulmicort Turbohaler®)
Easyhaler® 1st choice as per adult asthma guidelines due to cost.
Pulmicort® 2nd choice, alternative device as per adult asthma guidelines due to cost.
First Choice:
Beclometasone Dipropionate  (Clenil Modulite®)
CFC-free first choice for children (5-12). For use with Volumatic spacer device
Restricted Drug  Ciclesonide  (Alvesco®)
Restricted to use by Respiratory medicine. For use in patients unable to tolerate other steroid inhalers due to oral thrush
03.02.02 Compound Corticosteroid/ Long acting beta-agonist inhalers
Budesonide and Formoterol   (DuoResp Spiromax®)
First choice for patients aged 18 years and older.
Prescribe by brand as devices are not interchangeable
To be used only in new patients or after a review by a healthcare professional and counselling of patient to ensure appropriate use of the device.
There is no MART/SMART® equivalent with DuoResp.
Budesonide and formoterol  (Symbicort®)
Licensed from 6 years for maintenance therapy (SMART programme from 12). First choice in children 6-18 or in over 12s requiring the SMART programme.

Symbicort SMART® programme for flexibly adjusting dose – see supporting information (link below) Licensed for this in those 12 years and over.

Prescribe by brand as generic preparations available are a different device and are not interchangeable
Formoterol and beclometasone  (Fostair®)
ASTHMA: Second line choice where a combination is appropriate in patients 18 and over who can’t utilise the Symbicort Turbohaler® or where there is a preference for an MDI.
COPD: Second line choice
Fostair® is licensed for use with the AeroChamber Plus spacer device. It is stored in the refrigerator until dispensed after which it is given a 5 month expiry date.
Fostair® MART programme for flexibly adjusting dose is available with 100/6 inhaler
Formoterol and beclometasone  (Fostair NEXThaler®)
Dry powder inhaler, available as 200/6 and 100/6.
Asthma:To be used in line with Adult asthma guidance and combination inhaler step down guidance.
COPD: 200/6 is not licensed for use in COPD. To be used in line with COPD guidance and step down ICS guideline
Restricted Drug  Fluticasone and salmeterol  (Seretide®)
ASTHMA: First choice in patients aged 5-12 years, where an ICS/LABA MDI is required. Over 12 years, follow adult guidelines.
Compared to other combination products there is less flexibility in dosage adjustment.

COPD: Non Formulary for this indication
03.03 Cromoglicate, related therapy and leukotriene receptor antagonists
03.03.01 Cromoglicate and related therapy

Sodium cromoglicate was discontinued however is now available again, although its use is restricted.

03.03.02 Leukotriene receptor antagonists

  • Effective for some patients with asthma when used with an inhaled corticosteroid (Step 3 and above of the BTS Guidance). At Step 3 the preferred choice is a long acting beta-2 agonist (formoterol) followed by a trial of montelukast if control is not achieved.

  • Montelukast has not been shown to be more effective than a standard dose of inhaled corticosteroid but the two drugs appear to have an additive effect.
  • Leukotriene receptor antagonists may be of benefit in exercise-induced asthma and in those with concomitant rhinitis but they are less effective in those with severe asthma who are also receiving high doses of other drugs.
  • A one-month trial of montelukast will be sufficient to assess effectiveness for most patients. If there is not a measurable improvement in objective outcomes after this time the treatment should be stopped.
  • The Committee on Safety of Medicines (CSM) has advised that leukotriene receptor antagonists should not be used to relieve an attack of acute severe asthma and that their use does not necessarily allow a reduction in existing corticosteroid treatment.
First Choice:
03.03.03 Phosphodiesterase type-4 inhibitors
Restricted Drug  Roflumilast  (Daxas®)
For use in COPD in line with NICE TA 461 only
03.04 Antihistamines, hyposensitisation, and allergic emergencies
03.04.01 Antihistamines

  • Antihistamines are used in the treatment of allergic disorders although they may not relieve all symptoms satisfactorily. They are more effective in the early phase (sneezing, ocular itching and rhinorrhea) than in the late phase (nasal congestion).

  • Antihistamines enhance the effects of topical corticosteroids on the nasal mucosa in seasonal allergic rhinitis. They are more effective if taken as a regular dose rather than as ’rescue’ medication

  • Cetirizine and loratadine are relatively non-sedating agents, which are preferred for long-term or outpatient use e.g. in allergic rhinoconjunctivitis. They are less likely than chlorphenamine to interfere with driving in adults or learning in children. Nevertheless patients should be advised that sedation can occur and that it may affect performance of skilled tasks (e.g. driving); excess alcohol should be avoided.

  • Cetirizine may be slightly more effective than loratadine. It is renally excreted to a greater extent and is appropriate where drug interactions may render loratadine unsuitable.

  • Corticosteroid nasal sprays are appropriate as first-line treatment for allergic rhinitis.

  • Cumulative anticholinergic medication use  has been shown to be associated with an increased risk for dementia. The long-term impact of prescribing these drugs should be considered when initiating them as the untoward effects may not be reversed by withdrawing them later down the line.

  • The British Society for Allergy & Clinical Immunology (BSACI) guidelines (in line with international guidelines) on urticaria recommend that the first- line treatment for urticaria should be new generation, non-sedating H1-antihistamines. If standard dosing is not effective then the dosage should be increased incrementally up to four times the standard licensed dose in adults and four times the standard licensed age-specific dose in children.


First Choice:
Cetirizine Hydrochloride 
Non sedating
First Choice:
Non sedating
Second Choice:
Chlorphenamine Maleate 
Short-term treatment of acute allergic reactions such as drug rash, insect bites and urticaria. Less effective in rhinitis. Use limited by sedation and psychomotor impairment making it unsuitable as a long-term treatment or in daytime activities such as driving.
Restricted Drug  Chlorphenamine injection 
Useful as an adjunct to adrenaline in the emergency treatment of anaphylaxis
Restricted Drug  Fexofenadine hydrochloride 
For those patients who experience sedation on high doses of other recommended choices only.
03.04.02 Allergen Immunotherapy
Restricted Drug  Grass pollen extract sublingual  (Grazax®)
Restricted to initiation by specialist allergist / respiratory clinicians in line with criteria below.
Patients should be assessed at the end of each season to ensure adequate response before continuation
Restricted Drug  Mepolizumab  (Nucala®)
Asthma. For use by specialist respiratory clinician in line with NICE TA 431 to treat severe refractory eosinophilic asthma only.

Date of entry of decision to Formulary: March 2017
Restricted Drug  Grass pollen extract subcutaneous   (Pollinex®)
Restricted to initiation by specialist allergist / respiratory clinicians in line with criteria below
03.04.02 Omalizumab
Restricted Drug  Omalizumab  (Xolair®)
Chronic spontaneous urticaria in line with NICE TA 339 only. AT UHL prescribing is through the allergy clinic at Glenfield
Date of entry of decision to formulary: September 2015

Restricted Drug  Omalizumab  (Xolair®)
Asthma. For use by specialist respiratory clinicians only for patients attending difficult asthma clinic. Prescribing only in line with NICE TA 278.
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: April 2013

03.04.03 Allergic emergencies
03.04.03 Anaphylaxis
Anaphylaxis may be caused by allergic reaction to blood products, vaccines, drugs, insect stings, foods (e.g. nuts) etc. Prompt treatment of symptoms such as laryngeal oedema, hypotension and bronchospasm is essential.
Initial treatment:

  • Secure airway, if patient is hypotensive lay them flat and raise feet, give oxygen where available.

  • Administer adrenaline (epinephrine) 0.5mg (i.e. 0.5mL adrenaline 1:1000) by intramuscular* injection. Repeat after 5 minutes if no improvement, then give chlorphenamine IM (10-20mg).

  • If severe/recurrent reactions or history of asthma give hydrocortisone (100-500mg). If shock is unresponsive to drugs also give intravenous fluids 20mL/kg body weight (crystalloid preferred).

  • Note: use inhaled salbutamol if bronchospasm is present and does not respond to treatment.

  • *Adrenaline given subcutaneously is absorbed erratically - avoid this route.

  • Intravenous adrenaline should be given very cautiously (only when patient is profoundly shocked). It must be diluted 1 in 10 with 0.9% sodium chloride (to make a 1 in 10,000 dilution), given into a large vein at a maximum rate of 1mL per minute with ECG monitoring. Stop when response obtained (risk of serious arrhythmias).
03.04.03 Angioedema
Link   NHSE Commissioning Policy: Treatment of Acute Attacks in Hereditary Angiodema (Adult)
Restricted Drug  C1-Esterase Inhibitor   (Berinert®)
High cost drug excluded to tariff. NHSE commissioned
Restricted Drug  Icatibant  
High cost drug excluded to tariff. NHSE commissioned
03.04.03 Self-administration of adrenaline (epinephrine)

  • Auto-injectors are available for self use by patients who are at risk of an anaphylactic reaction.

  • They should be prescribed on an individual basis by a specialist in allergy. 

  • The preferred choice in Leicestershire is Jext. Epipen is available on request.

  • Emerade is non formulary for patient use but a care plan is in place for safety reasons.  It may be used in emergency boxes at UHL for use by professional staff.

  • The BNF notes that Injection technique is device specific.

  • To ensure patients receive the auto-injector device that they have been trained to use, prescribers should specify the brand to be dispensed. 

  • Patients should carry two pens with them at all times for emergency ’on the spot’ use in line with MHRA advice.
Link   Allergy - Emergency Action Plan with Antihistamine
Link   Allergy - Emergency Action Plan with Emerade
Link   Allergy - Emergency Action Plan with EpiPen
Link   Allergy - Emergency Action Plan with Jext
Link   MHRA Advice: Adrenaline auto-injector advice for patients: after every use, an ambulance should be called even if symptoms are improving, the individual should lie down with legs raised and, if at all possible, should not be left alone
03.05.02 Pulmonary surfactants
Restricted Drug  Poractant Alfa  
Specialist prescribing only
High cost drug excluded to tariff commissioned by NHSE
03.06 Oxygen
Link   Leicestershire Guidelines: Oxygen
03.07 Mucolytics
May reduce exacerbations in some patients with chronic obstructive pulmonary disease and a chronic productive cough. Therapy should be stopped if there is no benefit after a 4-week trial.
Restricted Drug  Dornase Alfa  (Pulmozyme®)
Classified Simple Amber in Leicestershire Traffic Lights
For cystic fibrosis.
High cost drug excluded to tariff. NHSE commissioned
Restricted Drug  Mannitol  
High cost drug excluded to tariff. NHSE commissioned

Date of entry of decision to Formulary: February 2013
Restricted Drug  Ivacaftor  
High cost drug excluded to tariff. NHSE commissioned
03.09 Cough preparations

  • Cough mixtures are considered Drugs of Limited Clinical Value

  • Few patients will need specific treatment for a cough. Many over-the-counter preparations contain several ingredients, some of which are likely to be ineffective or unnecessary.

  • There is no objective evidence that expectorants promote sputum clearance. Inhalation of steam is more likely to facilitate expectoration by keeping the patient’s airway well hydrated.



03.09.01 Cough suppressants
03.09.01 Palliative care
Link   Leicestershire Guidance: Prescribing Guide for Patients with Advanced Malignancy (See Breathlessness and Cough)
Link   LOROS: Guidelines for the Management of Common Symptoms in the Last Few Days of Life
03.10 Systemic nasal decongestants
Considered Drugs of Limited Clinical Value.

Inhalation of steam is an inexpensive alternative that may be beneficial. Addition of an aromatic product e.g. compound benzoin tincture may make this a more attractive therapy to use.

03.11 Antifibrotics
Restricted Drug  Pirfenidone  
For treatment of idiopathic pulmonary fibrosis in line with NICE TA 282 only.
For use by specialist respiratory physicians only
High Cost Therapy excluded to tariff commissioned by NHSE
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: July 2013

November 14: Not supported by TAS for patients with FVC 80-90%
Restricted Drug  Nintedanib 
In line with NICE TA 379 only by specialist Respiratory Consultants.

Date of entry of decision to Formulary: April 2016