Self-perceived quality of sleep among COPD patients in Greece: the SLEPICO study

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide accompanied by a substantial social and economic burden for the patient and the society. Poor sleep quality among COPD patients is frequently unnoticed and unaddressed by physicians and patients themselves, although it is a major source of further deterioration of these patients’ quality of life. The aim of the present study was to record the quality of sleep in COPD patients among the Greek population and correlate these findings with various features of these patients, using the COPD and Asthma Sleep Impact Scale (CASIS). This was a cross-sectional observational study. Forty different variables (demographics, vital sign measurements, COPD-related medical history parameters, comorbidities, CASIS questionnaire results, COPD assessment test, COPD severity based on spirometry measurements, COPD stage based on the ABCD assessment approach, inhaled COPD treatment report) were collected from 3454 nation-wide COPD patients (Greece). The study sample consisted of COPD patients, mainly male (73%) with a median age of 69 years and a median BMI of 27.2. More than half of COPD patients (60.6%) suffered from moderate disease severity and 23.8% from severe disease, while less than half (42.1%) suffered from at least one exacerbation of the disease over the last year prior study enrollment. About 14% reported frequent to very frequent issues affecting their sleep quality, between a fourth and a third of them reported occasional night sleep disturbances, and at least half of them reported no or very infrequent problems in their night sleep. Our study indicates that the COPD assessment test (CAT) and the spirometry-based disease severity can predict the poorness in the quality of sleep (F2,3451 = 1397.5, p < 0.001, adj. R2 = 0.45) as assessed by CASIS score, and that the latter also correlates with age (ρ = 0.122, p < 0.001) and disease duration (ρ = 0.104, p < 0.001). On the contrary, there appears to be no correlation between sleep quality and number of exacerbations. Finally, untreated patients with COPD suffer from poorer quality of sleep compared to treated subjects, independently of the use of inhaled corticosteroids (F2,3451 = 21.65, p < 0.001). The results of the SLEPICO study show that increased age, prolonged disease duration, and especially CAT score ≥ 10, and severe COPD stage, might act as important indicators for deterioration in the quality of sleep, with potential consequences in the daily routine of those patients, thus urging potentially for further pharmacological interventions or modifications.

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

Background The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. Objectives To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Methods and analysis Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. Ethics and dissemination This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registration ClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

Double-blind Placebo-controlled Randomized Clinical Trial to Assess the Efficacy of Montelukast in Mild to Moderate Respiratory Symptoms of Patients With Long COVID E-SPERANZA COVID PROJECT Study Protocol

BackgroundThe coronavirus disease-2019 (COVID-19) pandemic continues to affect the globe. After eighteen months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown and evidence-based, effective treatments for this condition remain unavailable. ObjectivesTo evaluate the efficacy of 10 mg oral montelukast every 24 hours versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving: exercise capacity; COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia); oxygen desaturation during exertion; functional status; and mortality. Methods and analysisPhase III, randomized, double-blind clinical trial. We will include 18 to 80 year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow up will finish 56 days after start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting treatment. Secondary outcomes a) Exercise capacity and oxygen saturation (1Min Sit-to-Stand test); b) Post-COVID-19 Functional Status scale; c) Other symptoms: asthenia, headache, mental confusion (brain fog), ageusia and anosmia (Likert scale); d) Use of healthcare resources; e) Mortality; f) Sick leave duration in days g) Side effects of montelukast. Ethics and disseminationThis study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. Trial registrationClinicalTrials.gov Identifier: NCT04695704 first posted on January, 5, 2021. EudraCT number 2021-000605-24). Prospectively registered.

Correlation of Composite Indices and COPD Assessment Test in Thai COPD Patients

Background: Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable chronic respiratory diseases. The BODE, ADO, DOSE are the composite indices taking into consideration for prognostication. In addition, COPD assessment test (CAT) score is associated with quality of life, taken for assessing symptoms severity and for personalizing treatments. Objective: To investigate the CAT score in Thai COPD patients according to their BODE, ADO, and DOSE in the influence of clinical parameters and outcomes. Methods: Medical records were reviewed between January 2016 and December 2016. BODE, ADO and DOSE was calculated based on their individual components. Results: Total 125 consecutive COPD patients were recruited. There was difference between CAT score among the GOLD stages classified (P = .02). There was significant difference of CAT between 4 BODE quartiles in cohort (P = .001).Thai COPD patients had the higher ADO index exhibit the higher CAT score than those with the lower ADO index (P = .001). There was no difference in CAT score between COPD with the higher and the lower DOSE index (P = .05). Conclusions: The higher CAT score found in Thai COPD patients with the higher composite indices of BODE and ADO. However, there was no difference in the DOSE index.

Skeletal muscle is associated with exercise tolerance evaluated by cardiopulmonary exercise testing in Japanese patients with chronic obstructive pulmonary disease

Decreasing exercise tolerance is one of the key features related to a poor prognosis in patients with chronic obstructive pulmonary disease (COPD). Cardiopulmonary exercise testing (CPET) is useful for evaluating exercise tolerance. The present study was performed to clarify the correlation between exercise tolerance and clinical parameters, focusing especially on the cross-sectional area (CSA) of skeletal muscle. The present study investigated 69 patients with COPD who underwent CPET. The correlations between oxygen uptake ($${{\dot{\text{V}} \text{O}}}_{2}$$ V ˙ O 2 ) at peak exercise and clinical parameters of COPD, including skeletal muscle area measured using single-section axial computed tomography (CT), were evaluated. The COPD assessment test score (ρ = − 0.35, p = 0.02) was weakly correlated with $${{\dot{\text{V}} \text{O}}}_{2}$$ V ˙ O 2 at peak exercise. In addition, forced expiratory volume in one second (FEV1) (ρ = 0.39, p = 0.0009), FEV1/forced vital capacity (ρ = 0.33, p = 0.006), and the CSA of the pectoralis muscles (PMs) (ρ = 0.36, p = 0.007) and erector spinae muscles (ECMs) (ρ = 0.39, p = 0.003) were correlated with $${{\dot{\text{V}} \text{O}}}_{2}$$ V ˙ O 2 at peak exercise. Multivariate analysis adjusted by age and FEV1 indicated that PMCSA was weakly correlated after adjustment (β value [95% confidence interval] 0.175 [0.03–0.319], p = 0.02). In addition, ECMCSA tended to be correlated, but not significantly after adjustment (0.192 [− 0.001–0.385] p = 0.052). The COPD assessment test, FEV1, FEV1/FVC, PMCSA, and ECMCSA were significantly correlated with $${{\dot{\text{V}} \text{O}}}_{2}$$ V ˙ O 2 at peak exercise.