Introduction

Introduction

The NICE clinical guideline on chronic obstructive pulmonary disease (COPD) states that COPD is characterised by airflow obstruction that is usually progressive and not fully reversible; it is predominantly caused by smoking. About 900,000 people in the UK have diagnosed COPD, and an estimated 2 million people have COPD that remains undiagnosed. COPD produces symptoms, disability and impaired quality of life, which may respond to pharmacological and other therapies that have limited or no impact on the airflow obstruction. Exacerbations often occur, during which there is a rapid and sustained worsening of symptoms beyond normal day-to-day variations.

The NICE clinical guideline on COPD defines COPD as follows:

  • Airflow obstruction is defined as a reduced FEV1/FVC ratio (where FEV1 is forced expired volume in 1 second and FVC is forced vital capacity), such that FEV1/FVC is less than 0.7.

  • If FEV1 is 80% predicted normal or more, a diagnosis of COPD should be made only in the presence of respiratory symptoms, for example, breathlessness or cough.

Classification of severity of airflow obstruction in COPD according to the NICE clinical guideline is shown in table 1.

Table 1 NICE classification of severity of airflow obstruction in COPD

Severity of airflow obstruction

Post-bronchodilator FEV 1 /FVC

FEV 1 % predicted

Post-bronchodilator

<0.7

≥80%

Stage 1: Milda

<0.7

50–79%

Stage 2: Moderate

<0.7

30–49%

Stage 3: Severe

<0.7

<30%

Stage 4: Very severeb

Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expired volume in 1 second; FVC, forced vital capacity.

a Symptoms should be present to diagnose COPD in people with mild airflow obstruction.

b Or FEV1 <50% with respiratory failure.

The NICE clinical guideline on COPD advises that all people who are still smoking should be encouraged to stop, and offered help to do so, at every opportunity.

The guideline recommends the following inhaled treatments for managing stable COPD. The list is not comprehensive but does include the key recommendations that relate to this evidence summary and the likely place in therapy of indacaterol/glycopyrronium.

  • Short-acting bronchodilators, as necessary, should be the initial empirical treatment for the relief of breathlessness and exercise limitation.

  • In people with stable COPD who remain breathless or have exacerbations despite using short-acting bronchodilators as needed, offer the following as maintenance therapy:

    • if FEV1 is 50% predicted or more: either a long-acting beta2 agonist (LABA) or a long-acting muscarinic antagonist (LAMA)

    • if FEV1 is less than 50% predicted: either a LABA with an inhaled corticosteroid (ICS) in a combination inhaler, or a LAMA. Consider a LAMA in addition to a LABA where an ICS is declined or not tolerated.

  • In people with stable COPD and an FEV1 of 50% predicted or more who remain breathless or have exacerbations despite maintenance therapy with a LABA:

    • consider a LABA with an ICS in a combination inhaler

    • consider a LAMA in addition to a LABA where an ICS is declined or not tolerated.

  • Offer a LAMA in addition to a LABA with an ICS to people with COPD who remain breathless or have exacerbations despite taking a LABA with an ICS, irrespective of their FEV1.

  • Consider a LABA with an ICS in a combination inhaler in addition to a LAMA for people with stable COPD who remain breathless or have exacerbations despite maintenance therapy with a LAMA, irrespective of their FEV1.

  • The choice of drug(s) should take into account the person's symptomatic response and preference, and the drug's potential to reduce exacerbations, its side effects and cost.

See the NICE pathway on COPD for more information.