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Formulary
Page last updated:
7 March 2021
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Management of Chronic Obstructive Pulmonary Disease (COPD)
The following recommendations are largely based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Global Strategy for Prevention, Diagnosis and Management of Chronic Obstructive Pulmonary Disease (COPD) 2019 Report. Where recommendations have been made by NICE (2019) this is indicated in the text. The information is supported by local respiratory specialists and is intended to guide and rationalise treatment choices when managing patients with COPD. Diagnosis is not covered in the guidance below. It is important to establish that patients meet the diagnostic criteria for COPD before commencing treatment.
Non inhaled prevention and maintenance strategies are essential in the management of COPD (see slider below)
Therapy should be reviewed annually and following an exacerbation. Treatment regimens should be patient-specific, and individualised. Patient preference should be considered when prescribing treatments. It is essential that patients can demonstrate the proper inhaler technique when prescribing an inhaler device; recheck patient technique at each visit to ensure continued correct use of the inhaler. Adherence to treatment regimens should also be checked. When discussing inhaled treatment options, consideration should also be given to the environmental impact of inhalers. Local and national resources which support patient training can be accessed via links at the bottom of the page.
Key:
- DPI = Dry powder inhaler; SMI = Soft mist inhaler; pMDI = Pressurised metered dose inhaler; BAI = Breath actuated inhaler
- SABA = Short-acting beta2 agonist; SAMA = Short-acting muscarinic antagonist; LABA = Long-acting beta2 agonist; LAMA = Long-acting muscarinic antagonist; ICS = Inhaled corticosteroid
- MRC = Medical Research Council breathlessness / dyspnoea scale; CAT = COPD Assessment Test
A guide to GOLD 2019
Non-inhaled prevention and maintenance strategies: including smoking cessation, vaccinations and pulmonary rehabilitation play a vital role in the management of COPD – see slider below for further details.
Initial inhaled therapy: Initial pharmacological management of COPD should be carried out according to the individualised assessment of symptoms and exacerbation risk and subsequent categorisation to one of four groups A, B, C, or D:
| MRC* 1 - 2; CAT < 10 | MRC* ≥ 3; CAT ≥ 10 | |
| ≥ 2 moderate exacerbations, or ≥ 1 leading to hospitalisation | Group C | Group D |
| 0 or 1 moderate exacerbations (not leading to hospital admission) | Group A | Group B |
* Note: GOLD 2019 refers to the modified MRC (mMRC) scale, which produces scores from 0 to 4; however, Devon formulary guidance utilises the standard MRC scale, which uses almost identical questions but has a range of scores from 1 to 5, and is routinely collected by GPs as part of the COPD indicator for the national Quality and Outcomes Framework (QOF).
For more information on the Medical Research Council (MRC) breathlessness / dyspnoea scale, click here
For more information on the COPD Assessment Test (CAT), click here
Follow-up inhaled therapy: Following implementation of therapy, patients should be reassessed for attainment of treatment goals and identification of any barriers for successful treatment. Consideration should be given to inhaler technique and adherence and non-inhaled approaches. Follow-up recommendations are intended to facilitate management of patients taking maintenance treatment(s) either early after initial treatment or after years of follow-up.
Following review, adjustments in treatment may be required.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Consider the predominant treatable trait to target: dyspnoea or exacerbations. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
See follow-up maintenance inhaled therapy sliders below.
Revisit the following treatments and plans at every review.
Smoking cessation
Smoking cessation has the greatest capacity to influence the natural history of COPD. At every opportunity, advise and encourage every person with COPD who is still smoking (regardless of their age) to stop, and offer them help to do so.
See 4.10.2 Nicotine dependence for formulary product listings and further information.
Additional support is available from Smoke Free Devon / OneSmallStep
Vaccinations
Pneumococcal vaccination and annual influenza vaccination should be offered to all patients with COPD.
Formulary guidance on the use of vaccines and the treatment of influenza is available.
Self-management plans
Self-management education and the issuing of a written action plan have been shown to improve outcomes for COPD.
Self-management plans should be individualised and written in collaboration with the patient with COPD and the family and carers (as appropriate). Self-management plans should be reviewed regularly.
Patients at risk of an exacerbation of COPD should be given an exacerbation action plan that encourages them to respond promptly to the symptoms of an exacerbation (see Management of acute exacerbations below).
Local COPD self-management plans are as follows:
NHS Devon COPD self-management plan
Pulmonary rehabilitation
Pulmonary rehabilitation includes education, exercise and self-management intervention, intended to improve symptoms, quality of life and physical and emotional participation in everyday activities. It is individually tailored and designed to optimise each person's physical and social performance and autonomy.
NICE guideline 115 states that pulmonary rehabilitation is recommended for patients who consider themselves functionally disabled by COPD (usually Medical Research Council [MRC] grade 3 and above), including those who have had a recent hospitalisation for an acute exacerbation. Pulmonary rehabilitation is not suitable for patients who are unable to walk, have unstable angina or who have had a recent myocardial infarction.
Rescue short-acting bronchodilators should be prescribed to all patients for immediate symptom relief.
Group A typical presentation
- 0 or 1 moderate exacerbation per year, without hospitalisation
- COPD Assessment Test (CAT) score less than 10
- Medical Research Council dyspnoea questionnaire (MRC) grade 1-2
Recommended inhaled treatment
- Long acting bronchodilator (LAMA or LABA), or
- Short acting bronchodilator (SAMA or SABA)
LAMAs or LABAs are preferred over short-acting agents, except for patients with only occasional dyspnoea and for immediate relief of symptoms in patients already on long-acting bronchodilators.
LAMA monotherapy:
Tiogiva (tiotropium, DPI)
- 18 micrograms (one capsule) once daily, or
Spiriva Respimat (tiotropium, SMI)
- 5 micrograms once daily, or
Seebri Breezhaler (glycopyrronium bromide, DPI)
- 55 micrograms inhaled daily
See section 3.1.2 Antimuscarinic bronchodilators
OR
LABA monotherapy:
Formoterol Easyhaler (formoterol, DPI) or Oxis Turbohaler (formoterol, DPI)
- 12 micrograms twice daily, or
Onbrez Breezhaler (indacaterol, DPI)
- 150 micrograms once daily, increased to maximum 300 micrograms once daily, or
Atimos Modulite (formoterol, pMDI)
- 12 micrograms twice daily via spacer, or
Soltel (salmeterol, pMDI)
- 50 micrograms twice daily via spacer
See section 3.1.1 Adrenoceptor agonists
OR
SABA monotherapy:
Salamol CFC-free (salbutamol, pMDI) or Salamol Easi-breathe (salbutamol, BAI) or Airomir Autohaler (salbutamol, BAI)
- 100-200 micrograms, when required up to 4 times daily via spacer, or
Bricanyl Turbohaler (terbutaline, DPI)
- 500 micrograms, when required up to 4 times daily
See section 3.1.1 Adrenoceptor agonists
OR
SAMA monotherapy:
Atrovent (ipratropium bromide, pMDI)
- 20-40 micrograms 3-4 times a day via spacer
See section 3.1.2 Antimuscarinic bronchodilators
Review
Following implementation of therapy, patients should be re-assessed for attainment of treatment goals and any barriers to successful treatment.
Treatment reviews should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
Continue treatment if benefit documented. If a change in treatment is considered, consider the predominant treatable trait to target: dyspnoea or exacerbations for follow-up maintenance therapy as shown below. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Rescue short-acting bronchodilators should be prescribed to all patients for immediate symptom relief.
Group B typical presentation
- 0 or 1 moderate exacerbation per year, without hospitalisation
- COPD Assessment Test (CAT) score 10 or above
- Medical Research Council dyspnoea questionnaire (MRC) grade 3 or above
Recommended inhaled treatment
- Long acting bronchodilator (LAMA or LABA), or
- Patients with severe breathlessness: LABA plus LAMA combination inhaler may be considered
LAMA monotherapy:
Tiogiva (tiotropium, DPI)
- 18 micrograms (one capsule) once daily, or
Spiriva Respimat (tiotropium, SMI)
- 5 micrograms once daily, or
Seebri Breezhaler (glycopyrronium bromide, DPI)
- 55 micrograms inhaled daily
See section 3.1.2 Antimuscarinic bronchodilators
OR
LABA monotherapy:
Formoterol Easyhaler (formoterol, DPI) or Oxis Turbohaler (formoterol, DPI)
- 12 micrograms twice daily, or
Onbrez Breezhaler(indacaterol, DPI)
- 150 micrograms once daily, increased to maximum 300 micrograms once daily, or
Atimos Modulite (formoterol, pMDI)
- 12 micrograms twice daily via spacer, or
Soltel (salmeterol, pMDI)
- 50 micrograms twice daily via spacer
See section 3.1.1 Adrenoceptor agonists
OR
LABA plus LAMA combination inhaler:
(For patients with severe breathlessness)
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
Review
Following implementation of therapy, patients should be re-assessed for attainment of treatment goals and any barriers to successful treatment.
Treatment reviews should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
Continue treatment if benefit documented. If a change in treatment is considered, consider the predominant treatable trait to target: dyspnoea or exacerbations for follow-up maintenance therapy as shown below. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Rescue short-acting bronchodilators should be prescribed to all patients for immediate symptom relief.
Group C typical presentation
- At least 2 moderate exacerbations per year, or at least one leading to hospitalisation
- COPD Assessment Test (CAT) score less than 10
- Medical Research Council dyspnoea questionnaire (MRC) grade 1-2
Recommended inhaled treatment
LAMA monotherapy:
Tiogiva (tiotropium, DPI)
- 18 micrograms (one capsule) once daily, or
Spiriva Respimat (tiotropium, SMI)
- 5 micrograms once daily, or
Seebri Breezhaler (glycopyrronium bromide, DPI)
- 55 micrograms inhaled daily
See section 3.1.2 Antimuscarinic bronchodilators
Review
Following implementation of therapy, patients should be re-assessed for attainment of treatment goals and any barriers to successful treatment.
Treatment reviews should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
Continue treatment if benefit documented. If a change in treatment is considered, consider the predominant treatable trait to target: dyspnoea or exacerbations for follow-up maintenance therapy as shown below. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Rescue short-acting bronchodilators should be prescribed to all patients for immediate symptom relief.
Group D typical presentation
- At least 2 moderate exacerbations per year, or at least one leading to hospitalisation
- COPD Assessment Test (CAT) score 10 or above
- Medical Research Council dyspnoea questionnaire (MRC) grade 3 or above
Recommended inhaled treatment
- LAMA monotherapy, or
- If highly symptomatic (e.g. CAT score greater than 20) consider LABA plus LAMA combination inhaler, or
- If patient displays asthmatic features, or features suggesting steroid responsiveness (see below) consider ICS plus LABA combination inhaler.
LAMA monotherapy:
Tiogiva (tiotropium, DPI)
- 18 micrograms (one capsule) once daily, or
Spiriva Respimat (tiotropium, SMI)
- 5 micrograms once daily, or
Seebri Breezhaler (glycopyrronium bromide, DPI)
- 55 micrograms inhaled daily
See section 3.1.2 Antimuscarinic bronchodilators
OR
LABA plus LAMA combination inhaler:
(if highly symptomatic (e.g. CAT score greater than 20))
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See sections 3.1.4 Combination inhalers
OR
ICS plus LABA combination inhaler:
(If asthmatic features, or features suggesting steroid responsiveness e.g. any previous, secure diagnosis of asthma or of atopy, a higher blood eosinophil count, substantial variation in FEV1 over time (at least 400 ml) or substantial diurnal variation in peak expiratory flow (at least 20%))
Note: These inhalers are listed in order of preference considering the environmental impact of the device (DPI vs pMDI) and acquisition cost
Fobumix Easyhaler (budesonide / formoterol fumarate dihydrate, DPI)
- 160/4.5micrograms: Two inhalations twice a day, or
- 320/9micrograms: One inhalation twice a day, or
Relvar Ellipta (fluticasone furoate / vilanterol trifenatate, DPI)
- 92/22micrograms: One inhalation once daily, or
Symbicort Turbohaler (budesonide / formoterol fumarate dihydrate, DPI)
- 200/6micrograms: Two inhalations twice a day, or
- 400/12micrograms: One inhalation twice a day, or
Fostair NEXThaler (beclomethasone / formoterol fumarate dihydrate, DPI)
- 100/6micrograms: Two inhalations twice a day, or
Duoresp Spiromax (budesonide / formoterol fumarate dihydrate, DPI)
- 160/4.5micrograms: Two inhalations twice a day, or
- 320/9micrograms: One inhalation twice a day, or
Luforbec (beclomethasone / formoterol fumarate dihydrate, pMDI)
- 100/6micrograms: Two inhalations twice a day via spacer
See section 3.1.4 Combination inhalers
Review
Following implementation of therapy, patients should be re-assessed for attainment of treatment goals and any barriers to successful treatment.
Treatment reviews should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
Continue treatment if benefit documented. If a change in treatment is considered, consider the predominant treatable trait to target: dyspnoea or exacerbations for follow-up maintenance therapy as shown below. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Exacerbation pathway should be used if both exacerbations and dyspnoea need to be targeted.
Before initiating a new drug therapy practitioners should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
- Consider other causes of breathlessness such as heart failure or atrial fibrillation.
Persistent breathlessness or exercise limitation despite LAMA or LABA monotherapy
- Step up to LABA plus LAMA combination inhaler.
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
Review patient:
- If persistent symptoms see further options below
Persistent breathlessness or exercise limitation despite LABA plus LAMA combination inhaler
Guidelines differ on their approach to managing these patients, and there is no strong evidence to provide clear direction. If there has been no symptomatic benefit (or a worsening of symptoms) following a recent initiation of LABA plus LAMA (e.g. within the first few weeks), GOLD suggests reverting to monotherapy may be considered (See sections 3.1.1 Adrenoceptor agonists and 3.1.2 Antimuscarinic bronchodilators). However, if patients have reported some benefit following initiation of LABA plus LAMA (but symptoms remain problematic, or have subsequently worsened), treatment options include the following:
GOLD recommends considering a switch of inhaler device or molecules (to a different LABA plus LAMA combination inhaler).
NICE Guideline 115 recommends stepping up from LABA plus LAMA to ICS plus LABA plus LAMA triple combination inhaler if day-to-day symptoms continue to adversely impact patient's quality of life.
Alternative LABA plus LAMA combination inhaler:
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium , DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
OR
ICS plus LABA plus LAMA triple combination inhaler:
Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol trifenatate, DPI)
- One inhalation (92micrograms / 55micrograms / 22micrograms) once daily, or
Trimbow NEXThaler (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , DPI)
- Two inhalations (88micrograms / 5micrograms / 9micrograms) twice daily, or
Trimbow pMDI (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (87micrograms / 5micrograms / 9micrograms) twice daily via spacer
Trixeo Aerosphere (budesonide / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (160micrograms / 5micrograms / 9micrograms) twice daily via spacer
See section 3.1.4 Combination inhalers
Review patient:
- Review triple therapy after 3 months and if no improvement in symptoms revert back to LABA plus LAMA combination inhaler and explore further treatment options such as those described in Other pharmacological treatments below.
- NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
- De-escalation guidance is detailed below
Persistent breathlessness or exercise limitation despite ICS plus LABA combination inhaler
- Switch to LABA plus LAMA combination inhaler if original indication for ICS was inappropriate, or there has been a lack of response to ICS, or if the patient is experiencing ICS side effects (including pneumonia), or
- Step up to ICS plus LABA plus LAMA triple combination inhaler.
NICE Guideline 115 recommends stepping up from LABA plus ICS to triple therapy if day-to-day symptoms continue to adversely impact patient's quality of life.
LABA plus LAMA combination inhaler:
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
OR
ICS plus LABA plus LAMA triple combination inhaler:
Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol trifenatate, DPI)
- One inhalation (92micrograms / 55micrograms / 22micrograms) once daily, or
Trimbow NEXThaler (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , DPI)
- Two inhalations (88micrograms / 5micrograms / 9micrograms) twice daily, or
Trimbow pMDI (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (87micrograms / 5micrograms / 9micrograms) twice daily via spacer
Trixeo Aerosphere (budesonide / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (160micrograms / 5micrograms / 9micrograms) twice daily via spacer
See section 3.1.4 Combination inhalers
Review patient:
- Review triple therapy after 3 months and if no improvement in symptoms revert back to LABA plus ICS combination inhaler and explore further treatment options such as those described in Other pharmacological treatments below
- NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
- De-escalation guidance is detailed below
De-escalation
Response to treatment escalation should always be reviewed; consider de-escalation if there is a lack of clinical benefit and/or side effects occur. De-escalation may also be considered in patients receiving treatment who return with resolution of some symptoms that subsequently require less therapy.
De-escalation should be undertaken carefully, ensuring that patients are aware of how to report decline in symptoms.
ICS should be discontinued if there has been a lack of response or patient experiencing side effects (including pneumonia); see Inhaled corticosteroids and pneumonia below.
Follow-up treatment does not depend on the ABCD assessment at diagnosis.
Exacerbation pathway should be used if both exacerbations and dyspnoea need to be targeted.
Before initiating a new drug therapy practitioners should:
- Assess adherence with existing therapies
- Assess inhaler technique, spacer use and possible side effects
- Assess non-inhaled prevention and maintenance strategies (see above)
Persistent exacerbations despite LAMA or LABA monotherapy
- Step up to LABA plus LAMA combination inhaler, or
- If patients have a history or findings suggestive of asthma or features suggesting steroid responsiveness (see below) ICS plus LABA combination inhaler may be preferable.
LABA plus LAMA combination inhaler:
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
OR
ICS plus LABA combination inhaler:
(If asthmatic features, or features suggesting steroid responsiveness e.g. any previous, secure diagnosis of asthma or of atopy, a higher blood eosinophil count, substantial variation in FEV1 over time (at least 400 ml) or substantial diurnal variation in peak expiratory flow (at least 20%))
Note: These inhalers are listed in order of preference considering the environmental impact of the device (DPI vs pMDI) and acquisition cost
Fobumix Easyhaler (budesonide / formoterol fumarate dihydrate, DPI)
- 160/4.5micrograms: Two inhalations twice a day, or
- 320/9micrograms: One inhalation twice a day, or
Relvar Ellipta (fluticasone furoate / vilanterol trifenatate, DPI)
- 92/22micrograms: One inhalation once daily, or
Symbicort Turbohaler (budesonide / formoterol fumarate dihydrate, DPI)
- 200/6micrograms: Two inhalations twice a day, or
- 400/12micrograms: One inhalation twice a day, or
Fostair NEXThaler (beclomethasone / formoterol fumarate dihydrate, DPI)
- 100/6micrograms: Two inhalations twice a day, or
Duoresp Spiromax (budesonide / formoterol fumarate dihydrate, DPI)
- 160/4.5micrograms: Two inhalations twice a day, or
- 320/9micrograms: One inhalation twice a day, or
Luforbec (beclomethasone / formoterol fumarate dihydrate, pMDI)
- 100/6micrograms: Two inhalations twice a day via spacer
See section 3.1.4 Combination inhalers
Review patient:
- NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
- Stop ICS if there are adverse effects (including pneumonia) or a reported lack of efficacy.
- De-escalation guidance is detailed below
Persistent exacerbations despite LABA plus LAMA combination inhaler
- Step up to ICS plus LABA plus LAMA triple combination inhaler, or
- Refer to Respiratory Consultant for consideration of other treatment options including azithromycin and roflumilast (see Other pharmacological treatments below).
NICE Guideline 115 recommends stepping up from LABA plus LAMA combination inhaler to triple therapy if day-to-day symptoms continue to adversely impact patient's quality of life, if they have a severe exacerbation (requiring hospitalisation), or they have 2 moderate exacerbations within a year.
ICS plus LABA plus LAMA triple combination inhaler:
Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol trifenatate, DPI)
- One inhalation (92micrograms / 55micrograms / 22micrograms) once daily, or
Trimbow NEXThaler (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , DPI)
- Two inhalations (88micrograms / 5micrograms / 9micrograms) twice daily, or
Trimbow pMDI (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (87micrograms / 5micrograms / 9micrograms) twice daily via spacer
Trixeo Aerosphere (budesonide / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (160micrograms / 5micrograms / 9micrograms) twice daily via spacer
See section 3.1.4 Combination inhalers
Review patient:
- NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
- De-escalation guidance is detailed below
Persistent exacerbations despite ICS plus LABA combination inhaler
- Step up to ICS plus LABA plus LAMA triple combination inhaler, or
- If original indication for ICS was inappropriate or there has been a lack of response to ICS, or if the patient is experiencing ICS side effects (including pneumonia) switch treatment to LABA plus LAMA combination inhaler.
NICE Guideline 115 recommends stepping up from LABA plus ICS to triple therapy if day-to-day symptoms continue to adversely impact patient's quality of life, or they have a severe exacerbation (requiring hospitalisation), or they have 2 moderate exacerbations within a year.
ICS plus LABA plus LAMA triple combination inhaler:
Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol trifenatate, DPI)
- One inhalation (92micrograms / 55micrograms / 22micrograms) once daily, or
Trimbow NEXThaler (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , DPI)
- Two inhalations (88micrograms / 5micrograms / 9micrograms) twice daily, or
Trimbow pMDI (beclomethasone / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (87micrograms / 5micrograms / 9micrograms) twice daily via spacer
Trixeo Aerosphere (budesonide / formoterol fumarate dihydrate / glycopyrronium , pMDI)
- Two inhalations (160micrograms / 5micrograms / 9micrograms) twice daily via spacer
See section 3.1.4 Combination inhalers
OR
LABA plus LAMA combination inhaler:
Anoro Ellipta (umeclidinium / vilanterol trifenatate, DPI),
- One inhalation (55micrograms / 22micrograms) once daily, or
Ultibro Breezhaler (indacaterol / glycopyrronium, DPI)
- 1 capsule (85micrograms / 43micrograms) inhaled once daily, or
Spiolto Respimat (tiotropium bromide / olodaterol hydrochloride, SMI)
- Two inhalations (5micrograms / 5micrograms) once daily
Bevespi Aerosphere (glycopyrronium / formoterol fumarate dihydrate, pMDI)
- Two inhalations (7.2micrograms / 5micrograms) twice daily
See section 3.1.4 Combination inhalers
Review patient:
- NICE Guideline 115 recommends use of ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
- De-escalation guidance is detailed below
Persistent exacerbations despite ICS plus LABA plus LAMA triple combination inhaler
- Refer to Respiratory Consultant for consideration of other treatment options including azithromycin and roflumilast (see Other pharmacological treatments below).
- Stop ICS if there are adverse effects (including pneumonia) or a reported lack of efficacy.
De-escalation
Response to treatment escalation should always be reviewed; consider de-escalation if there is a lack of clinical benefit and/or side effects occur. De-escalation may also be considered in patients receiving treatment who return with resolution of some symptoms that subsequently require less therapy.
De-escalation should be undertaken carefully, ensuring that patients are aware of how to report decline in symptoms.
ICS should be discontinued if there has been a lack of response or patient experiencing side effects (including pneumonia); see Inhaled corticosteroids and pneumonia below.
Physicians should remain vigilant for pneumonia and other infections of the lower respiratory tract (i.e. bronchitis) in patients with COPD who are treated with inhaled products that contain steroids because the clinical features of such infections and exacerbations frequently overlap (see Lower respiratory tract infections).
Any patient with severe COPD who has had pneumonia during treatment with ICS should have their treatment reconsidered.
NICE Guideline 115 recommends use of an ICS should be reviewed at least annually and the reason for ongoing ICS use documented in the patient's medical records.
Oral steroids
The use of oral corticosteroids as maintenance treatment is not generally recommended. In a few patients with advanced COPD maintenance treatment with oral steroids may be needed if they cannot be withdrawn after an exacerbation. In these cases the dose should be kept as low as possible and consideration given to osteoporosis prophylaxis (see 6.6 Drugs affecting bone metabolism).
Oral theophylline
Theophylline exerts a small bronchodilator effect in stable COPD, associated with modest symptomatic benefits. Plasma levels and interactions need to be monitored (see 3.1.3 Theophylline)
Mucolytic therapy
Mucolytic therapy can be considered for patients with a chronic productive cough and continued only if there is symptomatic improvement following a 4-week trial (see 3.7 Mucolytics).
Do not routinely use mucolytic drugs to prevent exacerbations in people with stable COPD (NICE NG115).
Oral prophylactic antibiotic therapy
NICE Guideline 115 makes the following recommendations regarding the use of prophylactic oral antibiotics.
Refer to respiratory consultant before commencing prophylactic antibiotic therapy.
Before offering prophylactic antibiotics, ensure that the person has been considered for:
- sputum culture and sensitivity (including tuberculosis culture), to identify other possible causes of persistent or recurrent infection that may need specific treatment (for example, antibiotic-resistant organisms, atypical mycobacteria or Pseudomonas aeruginosa)
- training in airway clearance techniques to optimise sputum clearance
- a CT scan of the thorax to rule out bronchiectasis and other lung pathologies
Consider azithromycin (usually 250 mg 3 times a week) for at least three months for people with COPD if they:
- do not smoke and
- have optimised non-pharmacological management and inhaled therapies, relevant vaccinations and (if appropriate) have been referred for pulmonary rehabilitation and
- continue to have 1 or more of the following, particularly if they have significant daily sputum production:
- frequent (typically 4 or more per year) exacerbations with sputum production
- prolonged exacerbations with sputum production
- exacerbations resulting in hospitalisation.
Note: Azithromycin is not licensed for use in this indication.
Before starting azithromycin, ensure the person has had an electrocardiogram (ECG) to rule out prolonged QT interval and baseline liver function tests. Advise people about the small risk of hearing loss and tinnitus associated with azithromycin, and tell them to contact a healthcare professional if this occurs.
Review prophylactic azithromycin after the first 3 months, and then at least every 6 months. Only continue treatment if the continued benefits outweigh the risks. Be aware that there are no long-term studies on the use of prophylactic antibiotics in people with COPD.
For people who are taking prophylactic azithromycin and are still at risk of exacerbations, provide a non-macrolide antibiotic to keep at home as part of their COPD rescue pack (see Management of acute exacerbations below).
It is not necessary to stop prophylactic azithromycin during an acute exacerbation of COPD.
See section 5.1.5 Macrolides
Roflumilast
Refer to respiratory consultant for consideration of roflumilast (hospital only) in line with NICE TA461
See section 3.3.3 Phosphodiesterase type-4 inhibitors
Nebulisers
NICE Guideline 115 states a nebuliser should be considered for people with distressing or disabling breathlessness despite maximum therapy with inhalers, and continue only if there is an improvement in symptoms, daily living activities, exercise capacity or lung function.
For more information see Nebulisation guidance
Oxygen therapy
Be aware that inappropriate use of oxygen therapy in patients with COPD may cause respiratory depression.
Formulary oxygen guidance including the Home Oxygen Order Form (HOOF) can be found here.
Devon Clinical Referral Guidelines (CRGs) on the use of oxygen can be found here:
COPD exacerbations are most commonly caused by respiratory tract infections. Symptoms usually last between 7 – 10 days, but some events may last longer.
The severity of the exacerbation and severity of the underlying disease will determine if it is managed in the inpatient or outpatient setting.
Bronchodilators
- SABAs with or without SAMAs are recommended as the initial bronchodilators to treat increased breathlessness during an acute exacerbation.
- Increase doses and/or frequency. It is recommended that patients use a metered dose inhaler one puff every hour for two or three doses and then every 2 – 4 hours based on response.
- Use spacers or air-driven nebulisers when appropriate. Do not use nebulisers continuously. Change patients back to hand-held inhalers as soon as the condition has stabilised.
- Continue long-acting bronchodilators during exacerbation or initiate as soon as possible before hospital discharge.
Glucocorticoids
- Consider prednisolone 30mg-40mg daily for 5-7 days in patients with a significant increase in breathlessness that interferes with daily activities and in all patients admitted to hospital unless contra-indicated (see 6.3.2 Glucocorticoid therapy).
- Consider osteoporosis prophylaxis for patients taking frequent courses of oral corticosteroids (see 6.6 Drugs affecting bone metabolism).
Antibiotics
- GOLD 2019 recommends that antibiotics should be used in patients who have three cardinal symptoms: increased dyspnoea, sputum volume and sputum purulence.
- GOLD 2019 recommends that antibiotics may be considered if only two of the above symptoms are present, if sputum purulence is one of the symptoms.
- GOLD 2019 also recommends that antibiotics should be given if patients require mechanical ventilation (invasive or non-invasive).
- Improvements in dyspnoea and sputum purulence suggest clinical success
- See Chapter 5 Infections - Lower Respiratory Tract Infections for further guidance and choice of antibiotics in acute COPD exacerbations
COPD Rescue Packs
Patients who have had an exacerbation within the last year and remain at risk of having an exacerbation should be given a COPD rescue pack of antibiotic and corticosteroid tablets to keep at home for use as part of their exacerbation action plan, if they understand and are confident about when and how to take these medicines (see Non inhaled prevention and maintenance strategies, above). Patients must be reminded to request replacement packs when used or expired.
Important: Please note these information leaflets are only relevant to prescriptions for standby supply of antibiotics and corticosteroid prescribed as described here, this is due to the specific nature of information contained regarding drugs and their doses.
Opiates can be used for the palliation of breathlessness in patients with end stage COPD unresponsive to other medical therapy in consultation with a specialist.
Use benzodiazepines, tricyclic antidepressants, major tranquilisers and oxygen where appropriate. Involve multidisciplinary palliative care teams and hospices.
- NHS Devon respiratory resources for health care professionals
- NHS Devon greener respiratory care resources
- Smoke Free Devon – Local information for GPs
- OneSmallStep – Local information for patients and all healthcare professionals
- 2019 GOLD Report
- NICE COPD resources
- RightBreathe.com – a website which contains resources to aid patient education and training on use of inhalers
NICE has produced a patient decision aid to help people with asthma and their healthcare professionals discuss their options for inhaler devices (available here); it is suitable for use by people aged 17 years and over, and many of the considerations are also applicable to patients with COPD.
Advice on how to obtain placebo inhalers can be obtained from the NHS Devon Medicines Optimisation Team, please contact: d-icb.medicinesoptimisation@nhs.net
