Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial.

BACKGROUND: Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19). METHODS: Placebo-controlled double-blind randomised multicentre trial. Patients aged ≥18 years, admitted to hospital for ≤48 h (not intensive care) with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription PCR test were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice-daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14). RESULTS: After randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on 1 February 2021. 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median (interquartile range) 9.0 (3-11) DAOH14 versus 9.0 (7-10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for one patient in the intervention group versus two patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for nine patients in the intervention group versus six patients receiving placebo (p=0.57). CONCLUSIONS: The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol-a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of "high-intensity" vs. "low-intensity" smoking cessation intervention in active smokers with chronic obstructive pulmonary disease.

BACKGROUND: Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD. METHODS: This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, "low intensity" group) or an intervention ("high-intensity" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and "buddy-matching" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months. DISCUSSION: The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.

Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death. TRIAL DESIGN: This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. PARTICIPANTS: 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals. INCLUSION CRITERIA: • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily. INTERVENTION AND COMPARATOR: Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No). BLINDING (MASKING): Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): This study requires 226 patients randomised 1:1 with 113 in each group. TRIAL STATUS: Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial.

BACKGROUND: Treatment with systemic corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) is associated with debilitating adverse effects. Therefore, strategies to reduce systemic corticosteroid exposure are urgently required and might be offered by a personalised biomarker-guided approach to treatment. The aim of this study was to determine whether an algorithm based on blood eosinophil counts could safely reduce systemic corticosteroid exposure in patients admitted to hospital with acute exacerbations of COPD. METHODS: We did a multicentre, randomised, controlled, open-label, non-inferiority trial at the respiratory departments of three different university-affiliated hospitals in Denmark. Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV1/forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty. We randomly assigned patients (1:1) to either eosinophil-guided therapy or standard therapy with systemic corticosteroids. Both investigators and patients were aware of the group assignment. All patients received 80 mg of intravenous methylprednisolone on the first day. The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3 × 109 cells per L. On days when the eosinophil count was lower, prednisolone was not administered. If a patient was discharged during the treatment period, a treatment based on the last measured eosinophil count was prescribed for the remaining days within the 5-day period (last observation carried forward). The control group received 37·5 mg of prednisolone tablets daily from the second day for 4 days. The primary outcome was the number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT). Secondary outcomes included treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids. The non-inferiority margin was 1·2 days (SD 3·8). This trial is registered at ClinicalTrials.gov, number NCT02857842, and was completed in January, 2019. FINDINGS: Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses. There was no between-group difference for days alive and out of hospital within 14 days after recruitment: mean 8·9 days (95% CI 8·3-9·6) in the eosinophil-guided group versus 9·3 days (8·7-9·9) in the control group (absolute difference -0·4, 95% CI -1·3 to 0·5; p=0·34). Treatment failure at 30 days occurred in 42 (26%) of 159 patients in the eosinophil-guided group and 41 (26%) of 159 in the control group (difference 0·6%, 95% CI -9·0 to 10·3; p=0·90). At 30 days nine patients (6%) of 159 in the eosinophil-guided group and six (4%) of 159 in the control group had died (difference 1·9%, 95% CI -2·8 to 6·5; p=0·43). Median duration of systemic corticosteroid therapy was lower in the eosinophil-guided group: 2 days (IQR 1·0 to 3·0) compared with 5 days (5·0 to 5·0) in the control group, p<0·0001. INTERPRETATION: Eosinophil-guided therapy was non-inferior compared with standard care for the number of days alive and out of hospital, and reduced the duration of systemic corticosteroid exposure, although we could not entirely exclude harm on some secondary outcome measures. Larger studies will help to determine the full safety profile of this strategy and its role in the management of COPD exacerbations. FUNDING: The Danish Regions Medical Fund and the Danish Council for Independent Research.

Effect of tele-health care on quality of life in patients with severe COPD: a randomized clinical trial.

Background and objective: Telemonitoring (TM) of patients with COPD has gained much interest, but studies have produced conflicting results. We aimed to investigate the effect of TM with the option of video consultations on quality of life (QoL) in patients with severe COPD. Patients and methods: COPD patients at high risk of exacerbations were eligible for the 6-month study and a total of 281 patients were equally randomized to either TM (n=141) or usual care (n=140). TM comprised recording of symptoms, oxygen saturation, spirometry, and video consultations. Algorithms generated alerts if readings breached thresholds. Both groups filled in a health-related QoL questionnaire (15D©) and the COPD Assessment Test (CAT) at baseline and at 6 months. Within-group differences were analyzed by paired t-test. Results: Most of the enrolled patients had severe COPD (86% with Global Initiative for Chronic Obstructive Lung Disease stage 3 or 4 and 45% with admission for COPD within the last year, respectively). No difference in drop-out rate and mortality was found between the groups, and likewise there was no difference in 15D or CAT at baseline. At 6 months, a significant improvement of 0.016 in 15D score (p=0.03; minimal clinically important difference 0.015) was observed in the TM group (compared to baseline), while there was no improvement in the control group -0.003 (p=0.68). After stratifying 15D score at baseline to <0.75 or ≥0.75, respectively, there was a significant difference in the <0.75 TM group of 0.037 (p=0.001), which is a substantial improvement. No statistically significant changes were found in CAT score. Conclusion: Compared to the nonintervention group, TM as an add-on to usual care over a 6-month period improved QoL, as assessed by the 15D questionnaire, in patients with severe COPD, whereas no difference between groups was observed in CAT score.

Do telemedical interventions improve quality of life in patients with COPD? A systematic review.

OBJECTIVE: Telehealth is an approach to disease management, which may hold the potential of improving some of the features associated with COPD, including positive impact on disease progression, and thus possibly limiting further reduction in quality of life (QoL). Our objective was, therefore, to summarize studies addressing the impact of telehealth on QoL in patients with COPD. DESIGN: Systematic review. METHODS: A series of systematic searches were carried out using the following databases: PubMed, EMBASE, Cochrane Controlled Trials Register, and ClinicalTrials.gov (last updated November 2015). A predefined search algorithm was utilized with the intention to capture all results related to COPD, QoL, and telehealth published since year 2000. OUTCOME MEASURES: Primary outcome was QoL, assessed by validated measures. RESULTS: Out of the 18 studies fulfilling the criteria for inclusion in this review, three studies found statistically significant improvements in QoL for patients allocated to telemedical interventions. However, all of the other included studies found no statistically significant differences between control and telemedical intervention groups in terms of QoL. CONCLUSION: Telehealth does not make a strong case for itself when exclusively looking at QoL as an outcome, since statistically significant improvements relative to control groups have been observed only in few of the available studies. Nonetheless, this does not only rule out the possibility that telehealth is superior to standard care with regard to other outcomes but also seems to call for more research, not least in large-scale controlled trials.

Effect of tele health care on exacerbations and hospital admissions in patients with chronic obstructive pulmonary disease: a randomized clinical trial.

BACKGROUND AND OBJECTIVE: Tele monitoring (TM) of patients with chronic obstructive pulmonary disease (COPD) has gained much interest, but studies have produced conflicting results. Our aim was to investigate the effect of TM with the option of video consultations on exacerbations and hospital admissions in patients with severe COPD. MATERIALS AND METHODS: Patients with severe COPD at high risk of exacerbations were eligible for the study. Of 560 eligible patients identified, 279 (50%) declined to participate. The remaining patients were equally randomized to either TM (n=141) or usual care (n=140) for the 6-month study period. TM comprised recording of symptoms, saturation, spirometry, and weekly video consultations. Algorithms generated alerts if readings breached thresholds. Both groups received standard care. The primary outcome was number of hospital admissions for exacerbation of COPD during the study period. RESULTS: Most of the enrolled patients had severe COPD (forced expiratory volume in 1 second <50%pred in 86% and ≥hospital admission for COPD in the year prior to enrollment in 45%, respectively, of the patients). No difference in drop-out rate and mortality was found between the groups. With regard to the primary outcome, no significant difference was found in hospital admissions for COPD between the groups (P=0.74), and likewise, no difference was found in time to first admission or all-cause hospital admissions. Compared with the control group, TM group patients had more moderate exacerbations (ie, treated with antibiotics/corticosteroid, but not requiring hospital admission; P<0.001), whereas the control group had more visits to outpatient clinics (P<0.001). CONCLUSION: Our study of patients with severe COPD showed that TM including video consultations as add-on to standard care did not reduce hospital admissions for exacerbated COPD, but TM may be an alternative to visits at respiratory outpatient clinics. Further studies are needed to establish the optimal role of TM in the management of severe COPD.

Long-term survival in patients hospitalized for chronic obstructive pulmonary disease: a prospective observational study in the Nordic countries.

BACKGROUND AND AIM: Mortality rate is high in patients with chronic obstructive pulmonary disease (COPD). Our aim was to investigate long-term mortality and associated risk factors in COPD patients previously hospitalized for a COPD exacerbation. METHODS: A total of 256 patients from the Nordic countries were followed for 8.7 ± 0.4 years after the index hospitalization in 2000-2001. Prior to discharge, the St George's Respiratory Questionnaire was administered and data on therapy and comorbidities were obtained. Information on long-term mortality was obtained from national registries in each of the Nordic countries. RESULTS: In total, 202 patients (79%) died during the follow up period, whereas 54 (21%) were still alive. Primary cause of death was respiratory (n = 116), cardiovascular (n = 43), malignancy (n = 28), other (n = 10), or unknown (n = 5). Mortality was related to older age, with a hazard risk ratio (HRR) of 1.75 per 10 years, lower forced expiratory volume in 1 second (FEV(1)) (HRR 0.80), body mass index (BMI) <20 kg/m(2) (HRR 3.21), and diabetes (HRR 3.02). Older age, lower BMI, and diabetes were related to both respiratory and cardiovascular mortality. An association was also found between lower FEV(1) and respiratory mortality, whereas mortality was not significantly associated with therapy, anxiety, or depression. CONCLUSION: Almost four out of five patients died within 9 years following an admission for COPD exacerbation. Increased mortality was associated with older age, lower lung function, low BMI, and diabetes, and these factors should be taken into account when making clinical decisions about patients who have been admitted to hospital for a COPD exacerbation.

Shuttle walking test as predictor of survival in chronic obstructive pulmonary disease patients enrolled in a rehabilitation program.

BACKGROUND: The Incremental Shuttle Walking Test (ISWT) is used to assess exercise capacity in chronic obstructive pulmonary disease (COPD) and is employed as an outcome measure for pulmonary rehabilitation. We studied the value of this test in predicting survival in COPD patients enrolled in a rehabilitation program. METHODS: A total of 416 patients performed an ISWT before entering a 7-week outpatient pulmonary rehabilitation program. Their survival was observed over a mean period of 4.5 years (range = 1.2-7.2 years). RESULTS: During the observation period, 169 (40.6%) patients died. Univariate analyses showed that the ISWT as well as age, gender, present and previous tobacco smoking, forced expiratory volume in 1 second, body mass index, oxygen saturation at rest, long-term oxygen therapy, Medical Research Council dyspnea score, and treatment with oral corticosteroids were significantly associated with survival. Multivariate analysis, including relevant confounders, revealed that low ISWT was independently associated with poor survival (P = .001). The association was not linear and the risk of dying increased markedly when ISWT was lower than 170 m (RR = 2.84, 95% CI: 2.05-3.93). CONCLUSION: This study shows that the ISWT is a strong and independent predictor of survival in patients with COPD enrolled in a rehabilitation program.

Long-term effects of 1-year maintenance training on physical functioning and health status in patients with COPD: A randomized controlled study.

PURPOSE: To examine whether maintenance training (MT) for 1 year improved the long-term effects of a 7-week chronic obstructive pulmonary disease (COPD) rehabilitation program. METHODS: After a 7-week outpatient rehabilitation program, 96 patients with COPD were randomized to either an MT group (n = 55) or a control group (n = 41). Both groups were requested to continue unsupervised training at home. The MT group received weekly supervised training the first 6 months, supervised training every second week the next 6 months, and finally no supervised training the last 6 months of the 18-month study period. Primary effect parameters were Endurance Shuttle Walk Test (ESWT) time and health status (St. George's Respiratory Questionnaire, SGRQ). Secondary effect parameters were adherence to supervised training, dropout rates, and hospitalization. RESULTS: Compared with the control group, the MT group had significantly better ESWT times at 3 and 6 months (+43.9 seconds; P= .03, and +75.1 seconds; P= .02) and insignificantly higher ESWT time at 12 months (+66.6 seconds; P= .40). SGRQ total score declined gradually after the 7-week program with no difference between the 2 groups, and after 18 months, the score was 1.7 units (95% confidence interval: -0.7 to 4.1) worse than at randomization. There was no difference between the 2 groups regarding dropout rates or hospitalization. DISCUSSION: Weekly MT for 12 months improved walking time but had no influence on health-related quality of life or hospital admissions, compared with unsupervised daily training at home. The effect of the MT was closely related to adherence to the program.

EuroQoL in assessment of the effect of pulmonary rehabilitation COPD patients.

BACKGROUND: The effect of pulmonary rehabilitation on EuroQol in COPD patients has not been investigated previously. METHODS/MATERIALS: Two hundred and twenty nine consecutive COPD patients who had completed a 7-week pulmonary rehabilitation programme were assessed with EuroQol five-dimension questionnaire (EQ-5D), endurance shuttle walk test (ESWT), and the St George's Respiratory Questionnaire (SGRQ) before and after the programme, and at the 3-month follow-up visit. RESULTS: Two hundred and two (88.4%) patients had FEV(1)<50% predicted and all but four (1.7%) had dyspnoea score at least 3 on MRC scale. At completion of the programme, statistical significant improvements were seen for ESWT 157.3s; p<0.001, EQ-5D utility score -0.019; p=0.03, EQ-5D VAS -2.1; p=0.056, SGRQ total score -2.8 units; p<0.001. The effects of rehabilitation on ESWT and SGRQ were maintained at 3-month follow-up (158.9s and -2.9 units), while the effect on EQ-5 utility decreased (0.013; p=0.18). At baseline, there was a maximum score ("ceiling effect") for EQ-5D utility and EQ VAS in 29 (12.7%) and five (2.2%) of the patients, respectively. After rehabilitation these number increased to 41 (17.9%) and seven (3.1%). CONCLUSIONS: In COPD patients receiving rehabilitation, responsiveness of EQ-5D utility was poor. One explanation might be a "ceiling effect" of this instrument.

[Rehabilitation of patients with chronic obstructive pulmonary disease. Effect of a 7-week programme after 12 months]. / Rehabilitering af patienter med kronisk obstruktiv lungesygdom. Tolvmånederseffekten af et syvugersprogram.

INTRODUCTION: Pulmonary rehabilitation in COPD improves exercise tolerance and health status, but these effects have been shown to decline after stopping the training programme. This study has examined the long-term effect on exercise tolerance and health status of a 7-week rehabilitation programme combined with extensive training at home. MATERIALS AND METHODS: 209 consecutive COPD patients who had completed a 7-week pulmonary rehabilitation programme were assessed with the endurance shuttle walk test (ESWT) and the St George's Respiratory Questionnaire (SGRQ) at baseline and at 7, 20, 33 and 59 weeks. RESULTS: 77 (36.8%) of the patients dropped out during the study period. Among the 132 patients who competed the 59-week evaluation, the initial improvement in the ESWT time was 100% (p < 0.001) and 3.8 units (p < 0.001) in the SGRQ. These effects were maintained at the 59-week evaluation (ESWT 63% above baseline; p = 0.02 and improved SGRQ 3.3 units compared with baseline; p < 0.001). CONCLUSION: A relatively simple and inexpensive 7-week rehabilitation programme with extensive training at home was sufficient to maintain the long-term effect on exercise tolerance and health status.

Nutritional status and long-term mortality in hospitalised patients with chronic obstructive pulmonary disease (COPD).

Patients with chronic obstructive pulmonary disease (COPD) often have difficulties with keeping their weight. The aim of this investigation was to study nutritional status in hospitalised Nordic COPD patients and to investigate the association between nutritional status and long-term mortality in this patient group. In a multicentre study conducted at four university hospitals (Reykjavik, Uppsala, Tampere and Copenhagen) hospitalised patients with COPD were investigated. Patient height, weight and lung function was recorded. Health status was assessed with St. George's Hospital Respiratory Questionnaire. After 2 years, mortality data was obtained from the national registers in each country. Of the 261 patients in the study 19% where underweight (BMI <20), 41% were of normal weight (BMI 20-25), 26% were overweight (BMI 25-30) and 14% were obese. FEV(1) was lowest in the underweight and highest in the overweight group (p=0.001) whereas the prevalence of diabetes and cardio-vascular co-morbidity went the opposite direction. Of the 261 patients 49 (19%) had died within 2 years. The lowest mortality was found among the overweight patients, whereas underweight was related to increased overall mortality. The association between underweight in COPD-patients, and mortality remained significant after adjusting for possible confounders such as FEV(1) (hazard risk ratio (95% CI) 2.6 (1.3-5.2)). We conclude that COPD patients that are underweight at admission to hospital have a higher risk of dying within the next 2 years. Further studies are needed in order to show whether identifying and treating weight loss and depletion of fat-free mass (FFM) is a way forward in improving the prognosis for hospitalised COPD patients.

Mortality in COPD patients discharged from hospital: the role of treatment and co-morbidity.

BACKGROUND: The aim of this study was to analyse mortality and associated risk factors, with special emphasis on health status, medications and co-morbidity, in patients with chronic obstructive pulmonary disease (COPD) that had been hospitalized for acute exacerbation. METHODS: This prospective study included 416 patients from each of the five Nordic countries that were followed for 24 months. The St. George's Respiratory Questionnaire (SGRQ) was administered. Information on treatment and co-morbidity was obtained. RESULTS: During the follow-up 122 (29.3%) of the 416 patients died. Patients with diabetes had an increased mortality rate [HR = 2.25 (1.28-3.95)]. Other risk factors were advanced age, low FEV1 and lower health status. Patients treated with inhaled corticosteroids and/or long-acting beta-2-agonists had a lower risk of death than patients using neither of these types of treatment. CONCLUSION: Mortality was high after COPD admission, with older age, decreased lung function, lower health status and diabetes the most important risk factors. Treatment with inhaled corticosteroids and long-acting bronchodilators may be associated with lower mortality in patients with COPD.

Depression, anxiety and health status after hospitalisation for COPD: a multicentre study in the Nordic countries.

Patients with chronic obstructive pulmonary disease (COPD) often report anxiety, depression and poor health status, not least if they experience repeated hospitalisations due to acute exacerbations. The aim of this study was to analyse the interrelationships between health status, anxiety, depression and physical status in COPD patients being discharged after hospitalisation. This was a prospective study of 416 patients in five university hospitals in each of the Nordic countries. Data included demographic information, lung function and co-morbidity. The Hospital Anxiety and Depression Scale and St. George's Respiratory Questionnaire (SGRQ) were applied to all patients. Both anxiety and depression were common among these patients. Anxiety was more common in women than in men (47% vs. 34%, P=0.009) and current smokers had a higher prevalence of both anxiety (54% vs. 37%) and depression (43% vs. 23%) than non-smokers (P<0.01). In general, the studied COPD patients had poor health status, especially those with anxiety, depression or both. Psychological status was independently related to all dimensions of SGRQ. Higher GOLD stages were significantly associated with increasing impairment in health status. In conclusion this multicentre study showed that anxiety and depression are common in patients with COPD, and, furthermore, that patients with psychological disorders have poor health status. Screening for depression and anxiety may help to identify patients with poor quality of life and an urgent need for intervention in order to improve their health status.

[Teenagers with asthma. A qualitative survey among teenagers with asthma of their expectations and attitudes when it comes to offered health care services]. / Asthma hos teenagere. En kvalitativ undersøgelse af ønsker og holdninger til sundhedsvaesenets tilbud blandt unge med asthma.

INTRODUCTION: We wanted to examine the factors that were of importance for the hospital outpatient treatment of teenagers with asthma. MATERIAL AND METHODS: A total of 89 teenagers received a postal questionnaire and an invitation to participate in a focus group interview on outpatient asthma follow-up. RESULTS: Only 16 answered the questionnaire and 7 participated in the interview. The importance of personal contact was stressed and the teenagers expected much from the personnel aiming to help them. In a questionnaire follow-up of initial non-responders, 82% still had asthma and 75% of these received asthma medication. DISCUSSION: The low participation rate and the high expectations explain why teenagers with asthma constitute a group of patients with less than optimal results of treatment.