Azithromycin during Acute Chronic Obstructive Pulmonary Disease Exacerbations Requiring Hospitalization (BACE). A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial.

Rationale: Azithromycin prevents acute exacerbations of chronic obstructive pulmonary disease (AECOPDs); however, its value in the treatment of an AECOPD requiring hospitalization remains to be defined.Objectives: We investigated whether a 3-month intervention with low-dose azithromycin could decrease treatment failure (TF) when initiated at hospital admission and added to standard care.Methods: In an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial, patients who had been hospitalized for an AECOPD and had a smoking history of ≥10 pack-years and one or more exacerbations in the previous year were randomized (1:1) within 48 hours of hospital admission to azithromycin or placebo. The study drug (500 mg/d for 3 d) was administered on top of a standardized acute treatment of systemic corticosteroids and antibiotics, and subsequently continued for 3 months (250 mg/2 d). The patients were followed for 6 months thereafter. Time-to-first-event analyses evaluated the TF rate within 3 months as a novel primary endpoint in the intention-to-treat population, with TF defined as the composite of treatment intensification with systemic corticosteroids and/or antibiotics, a step-up in hospital care or readmission for respiratory reasons, or all-cause mortality.Measurements and Main Results: A total of 301 patients were randomized to azithromycin (n = 147) or placebo (n = 154). The TF rate within 3 months was 49% in the azithromycin group and 60% in the placebo group (hazard ratio, 0.73; 95% confidence interval, 0.53-1.01; P = 0.0526). Treatment intensification, step-up in hospital care, and mortality rates within 3 months were 47% versus 60% (P = 0.0272), 13% versus 28% (P = 0.0024), and 2% versus 4% (P = 0.5075) in the azithromycin and placebo groups, respectively. Clinical benefits were lost 6 months after withdrawal.Conclusions: Three months of azithromycin for an infectious AECOPD requiring hospitalization may significantly reduce TF during the highest-risk period. Prolonged treatment seems to be necessary to maintain clinical benefits.

Validation of the French version of the Leicester Cough Questionnaire in chronic obstructive pulmonary disease.

Cough is one of the three major symptoms reported by chronic obstructive pulmonary disease (COPD) patients. The Leicester Cough Questionnaire (LCQ) is a questionnaire exploring the impact of cough, but it does not exist in French. The aim of this study was to develop a French version of LCQ and to assess its psychometrics properties. A forward-backward translation process was used to develop the French version of the LCQ. COPD patients completed LCQ and Cough and Sputum Assessment Questionnaire (CASA-Q) to determine concurrent validity, content validity and internal consistency. Two weeks later, the LCQ was repeated to evaluate the reproducibility. Seventy-four COPD patients were recruited. The concurrent validity showed highly significant correlations between all scores of LCQ and CASA-Q (p < 0.001). The content validity was good with domain total scores correlations ranging from 0.918 to 0.953. The LCQ domains and total scores showed a very good internal consistency with Cronbach's α coefficients ranging between 0.802 and 0.917. The test-retest reliability was high in COPD patients with no change in cough. In conclusion, The French version of the LCQ is a valid and reliable instrument to measure health status in COPD patients.

Dyspnea could be accurately assessed by a caregiver in hospitalized patients with respiratory diseases: Interrater reliability and agreement study.

BACKGROUND: The perception of dyspnea is a subjective feeling typically self-assessed by the patient. However, the assessment by a caregiver is sometimes required. OBJECTIVES: The primary aim was to compare patient self-assessment and caregiver assessment of dyspnea (interrater reliability) using the modified Borg and visual analog scale (VAS) in hospitalized patients. The secondary aim was to compare dyspnea assessment between the two scales for patients and caregiver (inter-instrument reliability). METHODS: Self-assessment of dyspnea intensity of hospitalized patients with respiratory diseases was compared with caregiver's assessment. Dyspnea intensity was measured using two scales, the modified Borg scale (0-10 scale) and the 10 cm VAS. Mean difference and 95% confidence interval (CI) between assessors (i.e. patient versus caregiver) were calculated for each scale. Inter- and intra-rater reliability was calculated using intraclass correlation coefficients (ICCs). RESULTS: A total of 254 patients were recruited. The mean differences between patient and caregiver ratings were 0.31 (95% CI: 0.09, 0.53) for the modified Borg scale and 0.36 (95% CI: 0.06, 0.65) for the VAS scale. Interrater reliability was good for both scales with ICC of 0.79 (95% CI: 0.73, 0.84) for VAS and 0.82 (95% CI: 0.77, 0.86) for the modified Borg scale. The mean differences in scores between scales were 0.93 (95% CI 0.69, 1.17) for patients' ratings and 0.88 (95% CI 0.72, 1.04) for caregiver's rating. The inter-instrument reliability was moderate to good and similar for both assessors. CONCLUSION: Dyspnea can be accurately estimated by caregivers when patients with lung diseases cannot self-report. Scores on the VAS to rate dyspnea were higher than the scores on the Borg scale.

Modification of COPD presentation during the last 25 years.

During the last decades progress has been made in the treatment of Chronic Obstructive Pulmonary Disease (COPD). We compared a random sample of patients admitted for an exacerbation in the period 2001-2005 (n = 101), with a random sample of patients hospitalized for the same reason in the period 1980-1984 (n = 51). Patients of the 2001-2005 cohort had a lower FEV1 (48 ± 3 vs. 41 ± 2% predicted, p = 0.01) for similar mean age, gender and body- mass index when compared to the historical sample. Co-morbidities, according to the Charlson's index, were more prevalent in the 2001-2005 cohort compared to the 1980-1984 cohort, with a reduction of hemoglobin (13.9 ± 0.2 gr/dl vs. 14.9 ± 0.2, p < 0.01) and higher prevalence of anemia in the most recent cohort. We found an increase in the use of cardiovascular drugs and respiratory medications over time with exception for the long-term use of oxygen. Despite lower FEV1 and more prevalent co-morbidities, no difference in length of hospitalization (13.6 ± 1.4 days vs. 12.7 ± 0.7 days, p = 0.52) and 30 months survival post-exacerbation was noted (66.6% vs. 69.3%, p = 0.85). Over the course of 20 years, the presentation of COPD patients admitted for an exacerbation seems to be changed towards a more severe phenotype with lower FEV1 and more co-morbidities. As the length of hospitalization and the overall survival were not different between the two samples, a currently improved management of COPD can be hypothesized.

Side effects of evidence-based medicine.

In the framework of an objective assessment of medical practices, it has become the rule to limit preoperative examinations, including thoracic imaging, in asymptomatic patients with a low surgical risk (that is, in "good health"). The insistence on the avoidance of "unnecessary" technical examinations in patients in seemingly good health may disregard common symptoms and lead to untoward consequences for the patients as we recently experienced in our respiratory department: two patients were admitted, one for a cavitary tuberculosis and the other one for a small cell carcinoma. These patients had uneventfully undergone in the recent weeks ear, nose and throat procedures and gynaecologic surgical procedures, respectively, without preoperative chest radiography as they were considered "asymptomatic" at the time of surgery. Retrospectively, ordinary symptoms (cough in the patient with cavitary tuberculosis and shortness of breath in the patient with lung carcinoma) were present but did not "ring a bell" during the preoperative assessment.

Inspired fraction of carbon dioxide in oxygen supply to chronic pulmonary disease.

Hypoxemic patients with chronic obstructive pulmonary disease (COPD) are at risk of carbon dioxide (CO(2)) retention during oxygen therapy and hypercapnia in COPD is associated with an ominous prognosis. Rebreathing with oxygen mask is possible in practice and possibly affects CO(2) retention due to an increased inspired fraction of CO(2). Its effects on arterial partial pressure of CO(2) during oxygen supply have, to the best of our knowledge, never been studied. We measured the inspired fraction of CO(2) in eighteen non-hypoxemic stable COPD patients with a capnograph during a 5 min trial with two different modes of oxygen supply (oxygen mask without reservoir bag and nasal prongs, respectively at a flow of 10 l/min and 2l/min). We found no significant increase in inspiratory CO(2) concentration. These findings suggest that inspired fraction of CO(2) does not increase markedly during controlled oxygen therapy.