Abstract
Chronic obstructive pulmonary disease (COPD) symptoms in the morning, including dyspnea and sputum production, affect patients’ quality of life and limit their ability to carry out even simple morning activities. It is now emerging that these symptoms are associated with increased risk of exacerbations and work absenteeism, suggesting that they have a more profound impact on patients than previously thought. The development of validated patient-reported outcome (PRO) questionnaires to capture patients’ experience of COPD symptoms in the morning is, therefore, vital for establishing effective and comprehensive management strategies. Although it is well established that long-acting bronchodilators are effective in improving COPD symptoms, the limited available data on their impact on morning symptoms and activities have been obtained with non-validated PRO questionnaires. In this review, we discuss the impact of COPD symptoms in the morning and available tools used to evaluate them, and highlight specific gaps that need to be addressed to develop standardized instruments able to meet regulatory requirement. We also present available evidence on the effect of pharmacological therapies on morning symptoms.
Highlights
Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with substantial morbidity and mortality [1]
COPD symptoms in the morning are strongly associated with problems experienced by patients in performing simple morning activities, resulting in a noticeable impact on patients’ quality of life
These symptoms, which are pronounced in patients with severe COPD, often result in work absenteeism contributing to aggravate the already substantial economic burden imposed by COPD
Summary
Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with substantial morbidity and mortality [1]. In Phase III studies, once-daily glycopyrronium taken in the morning displayed a rapid onset of action on Day 1 which was faster than that of tiotropium [42], and produced a greater increase in FEV1 at 5 minutes post-dose (Table 1) and greater peak FEV1 and FEV1 AUC0–4 hours than placebo and tiotropium at Day 1 and Week 26 [42] This early bronchodilation following morning dose, could in turn provide quicker relief from symptoms in the morning, such as shortness of breath, which hinder patients’ ability to perform simple morning activities. In a 12-week, randomized, double-blind study budesonide/formoterol added to tiotropium was shown to rapidly improve lung function (mean treatment difference for FEV1 at 5 minutes post-dose 123 mL; p < 0.001) compared with tiotropium alone, mainly owing to the fast onset of action of formoterol [48] This was associated with significant improvements in morning symptoms, including breathlessness, as evaluated by the CDLM questionnaire, as well as increased patients’ ability to perform morning activities. The results of the study suggest that a fast-acting component might be useful to help control morning symptoms in patients on LABA/ICS treatment
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