Introduction

Chronic obstructive pulmonary disease is a progressive disease characterised by persistent airflow limitation associated with substantial morbidity and mortality.1 The primary symptoms of the disease are dyspnoea, cough and sputum production.1 Starting in 2011, until the latest revision of GOLD 2015, pulmonary function, symptoms/health status assessment (as assessed by mMRC, CAT or CCQ)2-4 and number of exacerbations are included in the COPD algorithm for patient classification and management.1

Recognising the importance of the severity of symptoms, patients are categorised in the A,C (few symptoms) or B,D (more symptoms) categories.1 Next, a measure of risk is included in the algorithm. Both low lung function (forced expiratory volume in 1 s (FEV1) below 50% of predicted) or previous exacerbations (more than 2 in the last year or a hospital admission) result in classification in high risk (C,D).1 The classification in A-D will lead to management suggestions in the GOLD guideline.

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Consequently, the decision tree for management is based on this classification. With this categorisation, GOLD recommendations attempt a more personalised approach to disease management.1 Symptom assessment is included in the three questionnaires used by GOLD (CAT, mMRC and CCQ) and in most patient-reported outcome questionnaires. However, none of them include a specific question for diurnal symptom variability, morning or night.1-5 CAT has a question on sleep, but it only assess whether the patient sleeps soundly or not.3 GOLD guidelines do not mention morning and night-time symptoms as targets for therapeutic interventions, and they do not offer a specific guidance on appropriate management strategies or pharmacological interventions for patients with COPD who report diurnal variability in their symptoms.1,6 Moreover, it appears that patients do not report symptom variability and do not modify treatment when symptoms worsen,6,7 and thus physicians are unlikely to discuss diurnal variability with patients.6,8

Not only asthma but also COPD shows diurnal variability in physiological spirometric parameters of lung function and peak expiratory flow (PEF).9,10 Recent studies have shown that COPD symptoms follow physiological diurnal variability and vary over time,7,11,12,13 as well as by geographical areas.7 Morning7,11-18 and night symptoms6,7,13,19-23 are prevalent and burdensome for patients with COPD, compromising patients’ ability to perform tasks throughout the day.7,8,11-15,24 It seems that patients experience the biggest increase in respiratory symptoms during the early hours of the morning, followed by another increase in the night time,11,13,16 especially in patients with severe COPD.13,15 This coincides with the circadian variation in lung function. In particular, morning symptoms have been found to be associated with worse health status,13,18 sleep quality,13 higher anxiety and depression,13 and more exacerbations.7,18 In the same way, night symptoms are associated with worse health status13,19 and seem to be able to predict future exacerbations.20 However, most of the studies concerning the variability of symptoms have only assessed morning or night symptoms in specific groups of COPD patients.

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Therefore, the aims of our study were to explore the prevalence of morning and night symptoms, their distribution in different GOLD stages and grades and their correlation with lung function and health status, as well as to longitudinally explore their role in predicting future events such as worsening of health status and exacerbations. The null hypothesis was that morning and/or night symptoms were a distinct phenotype of highly symptomatic patients not captured by CCQ.

We conducted this study in a real-life setting with the aim of having a high external validity, as a primary care population has been used. Moreover, we aimed at assessing both morning and night symptoms rarely assessed simultaneously, as previously mentioned, in other studies.

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Category: WHY