Median Number Of Exacerbations Research Articles

Home-Based Connected Devices Combined With Statistical Process Control for the Early Detection of Respiratory Exacerbations by Patients With Cystic Fibrosis: Pilot Interventional Study With a Pre-Post Design.

Currently, patients with cystic fibrosis do not routinely monitor their respiratory function at home. This study aims to assess the clinical validity of using different connected health devices at home to measure 5 physiological parameters to help prevent exacerbations on a personalized basis from the perspective of patient empowerment. A multicenter interventional pilot study including 36 patients was conducted. Statistical process control-the cumulative sum control chart (CUSUM)-was used with connected health device measures with the objective of sending patients alerts at a relevant time in order to identify their individual risk of exacerbations. Associated patient education was delivered. Quantitative and qualitative data were collected. One-half (18/36) of the patients completed the protocol through the end of the study. During the 12-month intervention, 6162 measures were collected with connected health devices, 387 alerts were sent, and 33 exacerbations were reported. The precision of alerts to detect exacerbations was weak for all parameters, which may be partly related to the low compliance of patients with the measurements. However, a decrease in the median number of exacerbations from 12 months before the study to after the 12-month intervention was observed for patients. The use of connected health devices associated with statistical process control showed that it was not acceptable for all patients, especially because of the burden related to measurements. However, the results suggest that it may be promising, after adaptations, for early identification and better management of exacerbations. ClinicalTrials.gov NCT03304028; https://clinicaltrials.gov/study/NCT03304028.

Reliability of comorbidity indices as predictive indicators for frequent severe chronic obstructive pulmonary disease exacerbations.

The relationship between comorbidities and chronic obstructive pulmonary disease (COPD) is two-sided. As the number of comorbidities increases, frequency of acute exacerbations of COPD (AECOPD) consequently increases. Comorbidity indices can be used to evaluate comorbidities while managing COPD patients. We aimed to compare comorbidity indices such as the Charlson comorbidity index (CCI), comorbidities in COPD index (COMCOLD) and COPD specific comorbidity test (COTE) regarding exacerbation frequency. Participants hospitalized for AECOPD were included in this bidirectional case-control study. Exacerbation severity, frequency, further exacerbations over a one-year follow-up period and CCI, COMCOLD, and COTE scores were recorded. High and low comorbidity groups were compared regarding AECOPD frequency, severity, and further exacerbations. Ninety-two patients were enrolled. The frequency of AECOPD was significantly higher in high-comorbidity groups (p= 0.026 for CCI; 0.015 for COTE; 0.012 for COMCOLD) than that in low-comorbidity groups. Severe AECOPD was significantly higher in all high-comorbidity groups according to the indices. Median number of exacerbations during the one-year follow-up period was significantly higher in the high-comorbidity groups defined by CCI [0 (0-4) vs. 1 (0-4), p<0.001 and COMCOLD 0 (0-4) vs. 1 (0-3), p= 0.007]. Comorbidities are among the most important risk factors for AECOPD. Managing comorbidities begins with their identification, followed by appropriate interventions. Therefore, using at least one comorbidity index during assessment ensures that comorbidities are not overlooked during diagnostic and therapeutic processes. CCI, COTE, and COMCOLD comorbidity indices can be used in predicting COPD exacerbations.

Real-World Characteristics of Patients with Severe Asthma prior to Starting Dupilumab: The ProVENT Study

Introduction: Dupilumab is approved for the treatment of severe type 2 (T2) asthma; however, the characteristics of patients receiving dupilumab in routine clinical practice are incompletely understood. This study describes the characteristics of patients with severe asthma before dupilumab treatment in a real-world setting. Methods: This interim analysis of an ongoing real-life study of dupilumab assessed baseline characteristics of the first patient cohort enrolled in the ProVENT study. Results: A total of 99 patients (59% females) were analyzed (17% received another biologic before dupilumab treatment and 15% were on maintenance oral corticosteroid treatment). Adult-onset asthma (>18 years) and an allergic phenotype were documented in 58% and 48% of patients, respectively. Median (interquartile range) age was 54 (40–61) years; the median number of exacerbations in the last 24 months was 1 (0–3); median fractional exhaled nitric oxide (FeNO) value was 38 (23–64) ppb; and median blood eosinophils (bEOS) count was 184 (8–505) cells/µL. According to the United Kingdom Severe Asthma Registry classification, 53% of patients had T2 intermediate asthma (bEOS ≥150 cells/µL or FeNO ≥25 ppb), 17% had T2 high asthma (bEOS ≥150 cells/µL and FeNO ≥25 ppb), and 4% had T2 low asthma (bEOS <150 cells/µL and FeNO <25 ppb). At least one GINA criterion for T2 airway inflammation was documented in 70% of patients. T2 comorbidities were observed in 64% of patients. Conclusions: This analysis suggests that patients eligible for dupilumab treatment display various clinical and biochemical characteristics rather than one clear-cut phenotype.

Burden and unmet need for specialist care in poorly controlled and severe childhood asthma in a Danish nationwide cohort

BackgroundAsthma is a common disease in childhood and adolescence with lifelong consequences particularly among those at risk of severe disease, poor control and/or frequent exacerbations. Specialist care is recommended for at-risk children and adolescents, yet access to specialist management in free-to-access healthcare settings remains poorly understood.MethodsA Danish nationwide cohort of children and adolescents aged 2–17 years with persistent asthma, defined as repeated redemption of inhaled corticosteroids (ICS) during 2015, were followed for two years, to identify at-risk children and adolescents comprising those with severe asthma (classified according to GINA 2020 guidelines), poor control (defined as use of 400/600 (ages 2–11/12 +) annual doses of short-acting bronchodilators), or frequent exacerbations (defined as use of oral steroids or hospitalization), and access to specialist care. The population is chosen due to detailed medical records in the setting of universal health care.ResultsThe cohort comprised of 29,851 children and adolescents (59% boys), with a median age of 9 years. While 17% of children were on high dose ICS, 22% were on daily ICS below GINA low dose cut-off. Prevalence of severe asthma (3.0–6.5%) was lower than poor asthma control (6.4–25%); both declined from childhood to adolescence. Exacerbations occurred in 7.1–9.0% of children, with median number of exacerbations being 1 (IQR 1–1). Despite being classified as having mild-to-moderate asthma, 15% had poor asthma control and 3.8% experienced exacerbation(s), respectively. While 61% of children with severe asthma and 58% with exacerbation-prone disease were in specialist care, only 24% with uncontrolled disease were receiving specialist care. Of children and adolescents using high-dose ICS, 71% were managed in primary care, while the use of additional controllers was more common in specialist care.ConclusionsThroughout childhood and adolescence, there was a high prevalence of severe asthma and poor control, although their prevalence declined with age. We demonstrate a large unmet need for specialist care among children with at-risk asthma, particularly among those with poorly controlled asthma, even in a system with free-to-access, tax-funded healthcare.

Real-life Cretan asthma registry focused on severe asthma: On behalf of 'The Cretan registry of the use of Biologics in Severe Asthma'.

Asthma diagnosis and management remains a challenging task for the medical community. The aim of the present study was to present the functional and inflammatory profiles of patients with difficult-to-treat asthma in a real-life clinical setting referred to the specialized asthma clinic at the University Hospital of Heraklion. The registry included a cohort of 267 patients who were referred to the severe asthma clinic. Patients were assessed with emphasis on the history of allergies, nasal polyposis or other comorbidities. Blood testing for eosinophils counts and total and specific IgE, and pulmonary function tests were performed at baseline. The median age of patients with asthma was 55 years old, 68.5% were women and 58.3% were never smokers. The vast majority presented with late onset asthma (75.7%), whereas eight (3%) patients were on oral corticosteroids. The median number of exacerbations during the last 12 months was 1 (0-3). Furthermore, 50.7% of patients had a positive serum allergy test, the median eosinophil count was 300 (188-508.5) cells/µl of blood and median total IgE level was 117.5 (29.4-360.5) IU/ml. Patients were retrospectively grouped in the following categories: Group 1, mild-moderate asthma; group 2, patients prescribed a step 4 or 5 asthma therapy according to Global Initiative for Asthma; and group 3, patients on biologic agents. Group 1 had significantly higher FEV1% than groups 2 and 3 (93.4 vs. 79.9 and 79.4%, respectively; P<0.001). Finally, the median Asthma Control Questionnaire 7 (ACQ7) score was 1.14, with patients from groups 2 and 3 presenting higher ACQ7 scores compared with group 1 patients as expected (1.1 and 2.1 vs. 0.7, respectively; P<0.001). To the best of our knowledge, this was the first real-life asthma study in Crete that demonstrated that severe asthmatics predominantly have late-onset asthma with airflow obstruction and uncontrolled symptoms.

Effect of N-acetylcysteine on exacerbations of bronchiectasis (BENE): a randomized controlled trial

BackgroundN-acetylcysteine is a classic mucolytic agent. This study aimed to investigate the efficacy of N-acetylcysteine on reducing the risk of exacerbations in bronchiectasis patients.MethodsA prospective, randomized, controlled trial was conducted between April 1, 2014 and December 31, 2016 in five general hospitals in Shandong Province, China. Adult bronchiectasis patients with at least two exacerbations in the past year were potentially eligible. Patients were randomly assigned to receive oral N-acetylcysteine (600 mg, twice daily, 12 months) or on-demand treatment.ResultsA total of 161 patients were eligible for randomization (81 to the N-acetylcysteine group and 80 to the control group). During the 12-month follow-up, the incidence of exacerbations in the N-acetylcysteine group was significantly lower than that in the control group (1.31 vs. 1.98 exacerbations per patient-year; risk ratio, 0.41; 95% CI, 0.17–0.66; P = 0.0011). The median number of exacerbations in the N-acetylcysteine group was 1 (0.5–2), compared with 2 (1–2) in the control group (U = − 2.95, P = 0.003). A total of 24.7% of the N-acetylcysteine group patients and 11.3% of the control group patients remained exacerbation-free throughout the 12-month follow-up (χ2 = 4.924, P = 0.026). Compared with the control group, the volume of 24-h sputum in the N-acetylcysteine group was significantly reduced (t = − 3.091, P = 0.002). Additionally, the N-acetylcysteine group showed a significant improvement in the quality of life. No severe adverse events were reported in the intervention group.ConclusionThe long-term use of N-acetylcysteine is able to reduce the risk of exacerbations for bronchiectasis patients in Shandong Province, China. The results of this study should be verified in a larger randomized controlled trial.Trial registrationClinicalTrials.gov (NCT02088216) (Registered date: March 5, 2014).

Anti-IgE Monoclonal Antibody (Omalizumab) in Refractory and Relapsing Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss): Data on Seventeen Patients.

To describe the efficacy and safety of omalizumab, an anti-IgE monoclonal antibody, in patients with refractory and/or relapsing eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA). We conducted a nationwide retrospective study including EGPA patients who received omalizumab. Response was defined as the absence of asthma and/or sinonasal exacerbations with a prednisone dosage of ≤7.5 mg/day (complete response) or >7.5 mg/day (partial response). Seventeen patients (median age 45 years) received omalizumab for severe steroid-dependent asthma (88%) and/or sinonasal involvement (18%). After a median follow-up of 22 months, 6 patients (35%) achieved a complete response, 5 patients (30%) achieved a partial response, and 6 patients (35%) had no improvement. The median Birmingham Vasculitis Activity Score decreased from 2.5 at baseline to 0.5 at 12 months. The median number of exacerbations per month decreased from 1 at baseline to 0 at 12 months, and the median forced expiratory volume in 1 second increased from 63% of the percent predicted at baseline to 85% of the percent predicted at 12 months. The median prednisone dosage decreased from 16 mg/day at baseline to 11 mg/day at 6 months and 9 mg/day at 12 months. Omalizumab was discontinued in 8 patients (47%) during follow-up, because of remission (12.5%), adverse event despite disease remission (12.5%), refractory disease (25%), or relapse (50%). Relapses included retrobulbar optic neuritis attributable to EGPA in 2 patients and severe asthma flare in 2 others. The results of this study suggest that omalizumab may have a corticosteroid-sparing effect in EGPA patients with asthmatic and/or sinonasal manifestations, but reducing the corticosteroid dose may also increase the risk of severe EGPA flares, which raises the question of the safety of omalizumab in patients with EGPA.

Seasonal variations in onset and exacerbation of inflammatory bowel diseases in children.

BackgroundStudies have suggested that inflammatory bowel diseases (IBD) follow a seasonal pattern with regard to their onset and exacerbations. The aim of this study is to determine if there is any seasonal pattern to the onset and exacerbation of IBD in the pediatric population and if the birth of children diagnosed with IBD follows a seasonal pattern.MethodsPatients between the ages of 1 and 21 years and with a diagnosis of IBD established between July 1992 and July 2012 were included. Their onset and exacerbations of IBD (year and season) were recorded. The birth dates of the patients were aggregated to determine whether a seasonal birth pattern existed amongst them.ResultsA total of 170 children were included in this study; 34 % of patients had their onset in the fall and 19 % of them had their onset in the summer. The total number of documented exacerbations was 358 and the median number of exacerbations was two, with a range of 1–11. IBD exacerbations were generally uniformly distributed throughout the year. We did not observe any specific season where children with IBD tended to be born.ConclusionsOur data suggests that the onset of symptoms of IBD tends to have a seasonal trend with the highest incidence in the fall. However, we did not observe any association between seasonality and exacerbations in the pediatric population. Moreover, there was no specific season in which children with IBD tended to be born in greater numbers.

Effect of Azithromycin Maintenance Treatment on Infectious Exacerbations Among Patients With Non–Cystic Fibrosis Bronchiectasis

Macrolide antibiotics have been shown beneficial in cystic fibrosis (CF) and diffuse panbronchiolitis, and earlier findings also suggest a benefit in non-CF bronchiectasis. To determine the efficacy of macrolide maintenance treatment for adults with non-CF bronchiectasis. The BAT (Bronchiectasis and Long-term Azithromycin Treatment) study, a randomized, double-blind, placebo-controlled trial conducted between April 2008 and September 2010 in 14 hospitals in The Netherlands among 83 outpatients with non-CF bronchiectasis and 3 or more lower respiratory tract infections in the preceding year. Azithromycin (250 mg daily) or placebo for 12 months. Number of infectious exacerbations during 12 months of treatment. Secondary end points included lung function, sputum bacteriology, inflammatory markers, adverse effects, symptom scores, and quality of life. Forty-three participants (52%) received azithromycin and 40 (48%) received placebo and were included in the modified intention-to-treat analysis. At end of study, the median number of exacerbations in the azithromycin group was 0 (interquartile range [IQR], 0-1), compared with 2 (IQR, 1-3) in the placebo group (P < .001). Thirty-two (80%) placebo-treated vs 20 (46%) azithromycin-treated individuals had at least 1 exacerbation (hazard ratio, 0.29 [95% CI, 0.16-0.51]). In a mixed-model analysis, change in forced expiratory volume in the first second of expiration (percent of predicted) over time differed between groups (F1,78.8 = 4.085, P = .047), with an increase of 1.03% per 3 months in the azithromycin group and a decrease of 0.10% per 3 months in the placebo group. Gastrointestinal adverse effects occurred in 40% of patients in the azithromycin group and in 5% in the placebo group (relative risk, 7.44 [95% CI, 0.97-56.88] for abdominal pain and 8.36 [95% CI, 1.10-63.15] for diarrhea) but without need for discontinuation of study treatment. A macrolide resistance rate of 88% was noted in azithromycin-treated individuals, compared with 26% in the placebo group. Among adults with non-CF bronchiectasis, the daily use of azithromycin for 12 months compared with placebo resulted in a lower rate of infectious exacerbations. This could result in better quality of life and might influence survival, although effects on antibiotic resistance need to be considered. clinicaltrials.gov Identifier: NCT00415350.

Immediate and long term effects of weight reduction in obese people with asthma: randomised controlled study

Objective: To investigate the influence of weight reduction on obese patients with asthma.Design: Open study, two randomised parallel groups.Setting: Private outpatients centre, Helsinki, Finland.Participants: Two groups of 19 obese patients...

Treatment of chronic obstructive pulmonary disease and its exacerbations in general practice

The high prevalence and chronicity of chronic obstructive pulmonary disease (COPD) imply that many of these patients are treated and controlled in primary-care centres, often without contact with specialized pneumologist care. We conducted the present study to evaluate the treatment administered in stable and exacerbated COPD in GP-setting clinics and to investigate which factors could be associated with the different prescriptions. This is a cross-sectional observational study of ambulatory COPD patients. General practitioners ( n=201) were selected throughout Spain by regionally stratified sampling. We recorded the physician-reported prescription drug use in ambulatory treatment of stable COPD and acute exacerbations of COPD through a standard questionnaire. Factors independently associated with the prescription of drugs were ascertained by multiple logistic regression analysis. Of 1078 questionnaires reviewed, 1001 fulfilled quality criteria. There were 878 men (88%) and 123 women (12%); 777 (78%) were smokers or ex-smokers with a mean age of 68 years. Mean FEV 1 was 47% predicted (% pred.) ( sd=13%). The median number of exacerbations was two per year (range=0–16). Regular treatment for COPD was received by 878 (88%): the most commonly used drugs were inhaled β 2-agonists (71%), theophyllines (53%) and inhaled corticosteroids (ICs) (50%), followed by mucolytics (25%), ipratropium bromide (23%), and oral corticosteroids (OCs) (4%). Treatment for exacerbations included inhaled bronchodilators (90%), antibiotics (89%), ICs (71%) and OCs (43%). Impairment of FEV 1 was the factor most strongly associated in multiple regression analysis with increasing drug prescription in stable COPD, except for mucolytics, while the number of previous acute exacerbations was the main factor associated with exacerbation treatment except for OCs, the use of which was associated with more impaired pulmonary function. A significant number of the treatments prescribed in primary care for stable and exacerbated COPD do not follow current recommendations. Impairment in FEV 1 is the factor most strongly associated with increasing prescription in stable COPD and the number of previous exacerbations is the main factor associated with exacerbation treatment.

Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease.

Exacerbations occur commonly in patients with moderate or severe chronic obstructive pulmonary disease (COPD) but factors affecting their severity and frequency or effects on quality of life are unknown. We measured daily peak expiratory flow rate (PEFR) and daily respiratory symptoms for 1 yr in 70 COPD patients (52 male, 18 female, mean age [+/- SD] 67.5 +/- 8.3 yr, FEV1 1.06 +/- 0.45 L, FVC 2.48 +/- 0.82 L, FEV1/FVC 44 +/- 15%, FEV1 reversibility 6.7 +/- 9.1%, PaO2 8.8 +/- 1.1 kPa). Quality of life was measured by the St. George's Respiratory Questionnaire (SGRQ). Exacerbations (E) were assessed at acute visit (reported exacerbation) or from diary card data each month (unreported exacerbation). In 61 (87%) patients there were 190 exacerbations (median 3; range, 1 to 8) of which 93 (51%) were reported. There were no differences in major symptoms (increase in dyspnea, sputum volume, or purulence) or physiological parameters between reported and unreported exacerbations. At exacerbation, median peak flow fell by an average of 6.6 L/min (p = 0.0003). Using the median number of exacerbations as the cutoff point, patients were classified as infrequent exacerbators (E = 0 to 2) or frequent exacerbators (E = 3 to 8). The SGRQ Total and component scores were significantly worse in the group that had frequent exacerbations: SGRQ Total score (mean difference = 14.8, p < 0.001), Symptoms (23.1, p < 0.001), Activities (12.2, p = 0.003), Impacts (13.9, p = 0.002). However there was no difference between frequent and infrequent exacerbators in the fall in peak flow at exacerbation. Factors predictive of frequent exacerbations were daily cough (p = 0.018), daily wheeze (p = 0.011), and daily cough and sputum (p = 0.009) and frequent exacerbations in the previous year (p = 0.001). These findings suggest that patient quality of life is related to COPD exacerbation frequency.