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Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial.

BACKGROUND: New evidence-based treatment options are required to avoid antibiotic overuse in acute bronchitis and to replace potentially inefficacious initial antibiotic treatment. OBJECTIVE: To evaluate the efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) compared to placebo in patients with acute bronchitis. DESIGN: Randomized, double-blind, placebo-controlled trial using a multi-stage adaptive design. SETTING: 36 primary care physicians (investigators) at the out-patient care setting. PATIENTS: 468 adults with acute bronchitis present < or = 48 hours, Bronchitis Severity Score (BSS) > or = 5 points, and informed consent. INTERVENTION: EPs 7630 or placebo (30 drops three times daily) for 7 days. MEASUREMENT: The primary outcome criterion was the change of BSS on day 7. RESULTS: The decrease of BSS from baseline to day 7 was 5.9 +/- 2.9 points under EPs 7630 (n = 233), and 3.2 +/- 4.1 points under placebo (n = 235). The 95% CI for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as [-3.359; -2.060] showing a significant superiority of EPs 7630 compared to placebo on day 7 (p < 0.0001). Working inability decreased to 16% in the EPs 7630 group compared to 43% in the placebo group (p < 0.0001). In addition, the duration of illness was significantly shorter for patients treated with EPs 7630 compared to placebo (p < 0.001). Within the first four days, onset of treatment effect was recognized in 53.6% of patients under EPs 7630 compared to 36.2% of patients under placebo, only (p < 0.0001). Adverse events (AEs) occurred in 36/468 patients (EPs 7630: 20/233 patients, placebo: 16/235 patients). All events were assessed as non-serious. CONCLUSION: EPs 7630 was superior in efficacy compared to placebo in the treatment of adults with acute bronchitis. Treatment with EPs 7630 clearly reduced the severity of symptoms and shortened the duration of working inability for nearly 2 days.

Acute Disease↗

Acute and chronic bronchitis. A practical management strategy.

Bronchitis is a common diagnosis in the primary care physician's office, especially during winter. Acute bronchitis is usually caused by viruses but a number of other pathogens may also be responsible. Therapy for acute bronchitis is generally supportive. Chronic bronchitis, characterized by prolonged sputum production, is most often caused by cigarette smoking, which decreases mucociliary transport velocity. This and other pathophysiologic effects of smoking can lead to exacerbations of the disease that may necessitate antimicrobial therapy. Antimicrobial agents and vaccines may have both prophylactic and therapeutic roles in the management of chronic bronchitis.

Acute Disease↗

Postal survey on asthma, chronic bronchitis and respiratory symptoms among adult Estonians and non-Estonians (FinEsS-study).

BACKGROUND: According to the data of the population census held in Estonia in 1989, the resident population consisted of 61.5% Estonians and 38.5% non-Estonians, the majority of them being Russians--30.3%. The aim of this study was to investigate the prevalence of asthma, chronic bronchitis and respiratory symptoms among the adults in these ethnic groups. METHODS: The study was a postal survey, similar in design to parallel studies currently in progress in Finland, Estonia and Sweden (FinEsS). RESULTS: The prevalence of physician-diagnosed asthma was 2.0%, being similar in men and women and in both Estonians and non-Estonians. The prevalence of physician-diagnosed chronic bronchitis was 10.5%. Compared with the non-Estonian population, the prevalence was much lower among Estonians (7.9% vs. 13.5%, p<0.001). Such a difference in prevalence was observed in all age groups. The high prevalence of chronic bronchitis in non-Estonians could be related to more extensive smoking habits, smoking indoors and probably ETS exposure. The defined OR between non-Estonians vs. Estonians after correcting for the influence of smoking habits, area of domicile, age, gender, and socioeconomic group was 1.30. A similar pattern of differences between Estonians and non-Estonians was observed in respiratory symptoms. CONCLUSION: This study revealed that the prevalence of physician-diagnosed asthma in Estonians and non-Estonians was the same. Physician-diagnosed chronic bronchitis was more frequent in non-Estonians than in Estonians. A significant difference was determined in the prevalence of respiratory symptoms, especially among those common to chronic bronchitis. The differences remained significant after correction for possible confounders.

Asthma↗

Studies of the familial aggregation of chronic bronchitis and obstructive airways disease.

The familial aggregation of chronic bronchitis and obstructive airways disease was investigated in a propositus population of 430 persons aged 45-54 years and 1340 of their first (1 degree), second (2degrees) and third (3 degrees ) order relatives. All subjects were screened in their homes using a modified British MRC respiratory disease questionnaire and a portable spirometer. 1 degree relatives of propositi with either chronic bronchitis or obstructive airways disease demonstrated up to a two-fold excess prevalence of chronic bronchitis when compared to 1 degree relatives of non-affected propositi. This excess prevalence of chronic bronchitis was independent of sex, cigarette smoking patterns, respiratory illness history, residence in a common household, geographical distribution within the study community and the presence of alpha1-antitrypsin Pi variants. The prevalence of chronic bronchitis in 1 degree relatives of diseased propositi was also greater than in 2 degrees relatives of diseased propositi, in whom the prevalence approximated that of the general population.

Adolescent↗

The patient's burden: physical and psychological effects of acute exacerbations of chronic bronchitis.

In this prospective qualitative study we evaluated the subjective perspectives of the quality of life of patients with chronic bronchitis. Individuals with diagnoses which fulfilled the clinical criteria of chronic bronchitis, i.e. daily production of sputum for at least three consecutive months in two consecutive years, were recruited into four focus groups from general practices in two industrial cities. Younger patients (those of pre-retirement age) of both sexes-a significant, but frequently 'invisible' minority in this patient population-were targeted. The groups were constituted with the aim of stimulating variation in the discussions. Twenty sufferers (10 males and 10 females, ranging in age from 30 to 86 years) were eventually included in the study; there were five in each group. Group discussions were recorded and transcribed verbatim and the data were analysed thematically. It was evident from the discussions that chronic bronchitis had led to a high degree of psychological distress in the participants, particularly in relation to dependency on medication, and disruption of social and family relationships. Acute exacerbations of chronic bronchitis (AECB) were met with dread. They brought about further reductions in quality of life, increased anxieties about breathlessness, fear of atmospheric pollution and of changes in and extremes of temperature, embarrassment about coughing up phlegm in public and suspicion of medical practitioners' motives if they were unwilling to prescribe antibiotics on request. Patients' health-related behaviour and beliefs were often contradictory. For example, AECB in some patients led to increased smoking. There were also gender and age differences; for example, it was the perception of males that they received more support from their partners than did females. Younger participants appeared more distressed by AECB than older ones. The results of this study suggest that raising the standard of care for patients with chronic bronchitis requires that greater attention be paid to patients' subjective experiences of the disease.

Acute Disease↗

Asthma and bronchitis in Sydney schoolchildren. II. The effect of social factors and smoking on prevalence.

During a study of the prevalence of asthma and bronchitis in Sydney schoolchildren, some social and environmental factors were documented to ascertain if these affected the prevalence of either of these diseases. Socioeconomic status obtained from father's occupation, area of residence, family size, nationality, country of birth and smoking habits were examined. Although small differences were found between groups, no consistent relationship was found between social class and lung disease with the exception of increased prevalence of asthma in boys in social class I and girls in social class II. There were no major associations with area of residence or with family size. Children who were born outside Australia tended to have less asthma and bronchitis than children born inside Australia and migrant children tended to first develop asthma several years after arriving in Australia. Bronchitis was found to be more common in children with an earlier history of bronchitis in infancy and early childhood. The prevalence of recent bronchitis in the group of children who smoked 20 or more cigarettes per week was higher than that in the nonsmoking group of children.

Adolescent↗

Evaluation and treatment of acute bronchitis at an academic teaching clinic.

BACKGROUND: Randomized controlled trials have demonstrated that antibiotics provide no benefit for acute bronchitis, yet 55 to 90% of patients who receive this diagnosis are treated with antibiotics. Given substantial data against antibiotics for acute bronchitis, it could be expected that physicians at academic teaching institutions would be less likely to prescribe antibiotics. However, limited data of antibiotic use for acute bronchitis in this setting has been published. METHODS: Charts of patients seen between January 1 and October 25, 2000, who received an ICD-9 diagnosis of acute bronchitis or upper respiratory infection (URI) at the University of Virginia internal medicine clinic were reviewed. Patients were excluded if they had no cough, chronic obstructive pulmonary disease, symptoms for > or = 3 weeks, or antibiotics for another reason. RESULTS: Of the 160 patients included in this study, 105 (66%) received an antibiotic. Multivariate analysis revealed that patients with increasing age (P = 0.002), purulent cough (P = 0.003), abnormal exam (P = 0.003), and comorbidities (P = 0.03) were most likely to receive an antibiotic. Smoking, duration of symptoms, gender, and race did not predict antibiotic use (P > 0.05). Macrolides accounted for 68% of antibiotics. Twenty-two (14%) of all patients received a chest radiograph and 72 (45%) received an inhaler. Of those who had chest radiographs negative for signs of infection, 76% received an antibiotic. CONCLUSION: In our teaching clinic, antibiotics were overused, whereas chest radiographs and inhalers were underused for the evaluation and treatment of acute bronchitis. Recently published guidelines will help curb use of antibiotics, but a more intensive intervention, including physician and patient education is probably necessary.

Acute Disease↗

Observational study of the natural history of eosinophilic bronchitis.

BACKGROUND: Eosinophilic bronchitis is an important cause of chronic cough. Treatment with inhaled corticosteroids is associated with a short-term improvement in cough and reduced sputum eosinophil count but the long-term outcome is uncertain. OBJECTIVE: To determine the long-term outcome in patients diagnosed with and treated for eosinophilic bronchitis. METHODS: We have performed a longitudinal study of symptoms, eosinophilic airway inflammation, spirometry and airway hyper-responsiveness in all patients diagnosed with eosinophilic bronchitis over 7 years. RESULTS: We identified 52 patients with eosinophilic bronchitis and longitudinal data of greater than 1 year (mean 3.1 years) was available in 32 patients, all of whom were treated with inhaled steroids. Three (9%) patients developed symptoms consistent with asthma and a methacholine PC20<8 mg/mL on one or more occasion. Five (16%) patients developed fixed airflow obstruction defined by a persistent post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity<70%. One (3%) patient had complete resolution of symptoms and eosinophilic airway inflammation off treatment. The remaining patients had ongoing eosinophilic airway inflammation and/or continuing symptoms. Multiple linear regression identified smoking, female gender and area under the curve of sputum eosinophil count over time as the most important predictors of decline in FEV1. CONCLUSIONS: The most common outcome in eosinophilic bronchitis is continuing disease and complete resolution is rare. Asthma and fixed airflow obstruction developed in relatively few patients. The most important factors associated with a more rapid decline in FEV1 were female gender, smoking and prolonged eosinophilic airway inflammation.

Administration, Inhalation↗

Office evaluation and treatment of elderly patients with acute bronchitis.

OBJECTIVES: To assess the office evaluation of seniors with uncomplicated acute bronchitis and to determine the association between elements of the clinical evaluation and antibiotic prescribing decisions. DESIGN: Cross-sectional chart review. SETTING: Seventy-seven community-based office practices in the Denver metropolitan area. PARTICIPANTS: Elderly fee-for-service Medicare patients. MEASUREMENTS: Medicare administrative data to identify patients with acute bronchitis; medical record review to confirm the diagnosis and record other clinical data. RESULTS: Of 198 elderly patients with acute bronchitis, the mean age+/-standard deviation was 76+/-8.6; 53% had at least one comorbid condition. Clinically important vital signs were frequently not recorded; temperature was missing from 34% of charts and pulse from 50% of charts. When recorded, significant vital sign abnormalities were uncommon, with 7% having a temperature of 100 degrees F and 8% having a pulse of 100 beats per minute or greater. However, antibiotics were prescribed to 83% of patients, with more than half of these prescriptions being for extended-spectrum antibiotics. Treatment with antibiotics was more common in men than women (92% vs 78%, P=.007) but was not associated with clinical factors including vital sign measurement, vital sign results, chest radiography, patient age, duration of illness, or the presence of comorbidities. CONCLUSION: The vast majority of seniors with acute bronchitis are treated with antibiotics, regardless of patient characteristics or the type of evaluation received. Reducing inappropriate antibiotic use in seniors with acute bronchitis may depend on improving the evaluation of these patients and encouraging clinicians to act appropriately on the results.

Acute Disease↗

IgG subclass specific antibody response in recurrent bronchitis.

The IgG subclass specific immune response against pneumococcal type 3 polysaccharide antigen before and after immunisation in healthy children and children with recurrent bronchitis was studied. Recurrent bronchitis was defined as three or more episodes a year, during at least two consecutive years, of bronchopulmonary infection, productive cough with or without fever, and/or diffuse rales by physical examination. Twenty five patients and 15 healthy children were selected. The patient group had lower concentrations of IgG1 and IgG2 specific pneumococcal antibodies compared with healthy children, regardless of whether or not the total IgG2 concentration was low. The children with recurrent bronchitis showed a greater increase in IgG1 and IgG2 antibodies after immunisation than the controls. It is concluded that children with recurrent bronchitis show a decreased humoral immune response to pneumococcal type 3 polysaccharide antigen. This finding suggests that a defect in the humoral immune response against polysaccharide antigens is an important cause of recurrent bronchitis in childhood.

Age Factors↗

Reassessment of inflammation of airways in chronic bronchitis.

The term chronic bronchitis has been criticised because it is associated with hypersecretion of mucus rather than bronchial inflammation. This study was designed to establish the presence or absence of clinical chronic bronchitis and measure pulmonary function in 45 patients about to undergo resection of the lung. The condition in the cartilaginous and small airways and the severity of the emphysema were then measured in the resected specimen. The results from 20 patients who had clinical chronic bronchitis were compared with those in 25 patients who did not. The data show that patients with chronic bronchitis had greater inflammation (a) on mucosal surfaces (p less than 0.05) of all bronchi larger than 2 mm luminal diameter and (b) around glands (p less than 0.005) and gland ducts (p less than 0.05) in bronchi larger than 4 mm diameter. A variable degree of inflammation was present in the submucosa of smaller bronchi. The groups had equivalent proportions of mucous glands and Reid's indices in central airways, and no differences were noted in measurements of pulmonary function, condition of small airways, or emphysema. These data show that the term chronic bronchitis is justified by inflammation of cartilaginous airways and suggest that this abnormality may be the cause of the chronic productive cough.

Bronchi↗

Bronchodilator treatment in moderate asthma or chronic bronchitis: continuous or on demand? A randomised controlled study.

OBJECTIVE: To examine the effect of bronchodilator treatment given continuously versus on demand on the progression of asthma and chronic bronchitis and to compare the long term effects of a beta 2 adrenergic drug (salbutamol) and an anticholinergic drug (ipratropium bromide). DESIGN: Two year randomised controlled prospective 'crossover' study in which patients were assigned to one of two parallel treatment groups receiving continuous treatment or treatment on demand. SETTING: 29 general practices in the catchment area of the University of Nijmegen. PATIENTS: 223 patients aged greater than or equal to 30 with moderate airway obstruction due to asthma or chronic bronchitis, selected by their general practitioners. INTERVENTIONS: 1600 micrograms salbutamol or 160 micrograms ipratropium bromide daily (113 patients) or salbutamol or ipratropium bromide only during exacerbations or periods of dyspnoea (110). No other pulmonary treatment was permitted. MAIN OUTCOME MEASURES: Decline in ventilatory function and change in bronchial responsiveness, respiratory symptoms, number of exacerbations, and quality of life. RESULTS: Among 144 patients completing the study, after correction for possible confounding factors the decline in forced expiratory volume in one second was -0.072 l/year in continuously treated patients and -0.020 l/year in those treated on demand (p less than 0.05), irrespective of the drug. The difference in the decline in patients with asthma was comparable with that in patients with chronic bronchitis (asthma: 0.092 v -0.025 l/year; chronic bronchitis: -0.082 v -0.031 l/year). Bronchial responsiveness increased slightly (0.4 doubling dose) with continuous treatment in chronic bronchitis, but exacerbations, symptoms, and quality of life were unchanged. Salbutamol and ipratropium bromide had comparable effects on all variables investigated. CONCLUSIONS: Continuous bronchodilator treatment without anti-inflammatory treatment accelerates decline in ventilatory function. Bronchodilators should be used only on demand, with additional corticosteroid treatment, if necessary.

Adult↗

Industrial bronchitis.

For many years there has been much argument whether workers in the dusty trades are prone to chronic bronchitis. In 1966 the Medical Research Council issued a report of a Select Committee which concluded that occupationally induced bronchitis did not play a significant part in the aetiology of airways obstruction in dust-exposed men. Since then epidemiological studies have demonstrated that the prolonged inhalation of dust leads to an increase in prevalence of cough and sputum. Furthermore, new physiological techniques have demonstrated a slight decrement in ventilatory capacity as a result of industrial bronchitis, and which is related to lifetime dust exposure. Unlike bronchitis induced by cigarette smoke, the predominant effect of industrial bronchitis is on large rather than small airways and the condition is not accompanied by emphysema.

Airway Obstruction↗

Prevalence and risk factors for chronic bronchitis and farmer's lung in French dairy farmers.

The prevalence of chronic bronchitis and of clinical farmer's lung was studied in 30 districts of the French Doubs province in relation to individual (age, sex, smoking) and geographical (altitude) factors. 5703 exclusively dairy farmers (response rate 83%) participated in the study by answering a medical questionnaire. Prevalences of chronic bronchitis and clinical farmer's lung were 9.3% and 1.4% respectively. A logistic regression model was used to evaluate risk factors for chronic bronchitis and clinical farmer's lung. A risk of chronic bronchitis was associated with male sex (p < 10(-4)), age (p < 10(-4)), smoker category (p < 10(-4)), and altitude (p < 10(-4)). A risk of clinical farmer's lung was associated with non-smokers (p < 0.05), and linearly with altitude (p < 10(-4)). Also there was a strong positive relation between chronic bronchitis and clinical farmer's lung (odds ratio 19.5 (95% confidence interval 12.1-31.4) after adjustment for confounding variables. The main finding of this study is the highly significant increase of prevalence of the diseases in relation to altitude.

Adolescent↗

Chlamydia pneumoniae and chronic bronchitis: association with severity and bacterial clearance following treatment.

BACKGROUND: A study was undertaken to evaluate Chlamydia pneumoniae chronic infection, other respiratory infections, and functional impairment in patients with chronic bronchitis (stage 1) and to examine chronic C pneumoniae infection, rate of acute exacerbations of chronic bronchitis, and rate of C pneumoniae eradication following antibiotic treatment (stage 2). METHODS: In the stage 1 study respiratory specimens from 42 patients with steady state chronic bronchitis were analysed for Gram staining, sputum culture, and C pneumoniae DNA detection by nested touchdown polymerase chain reaction (PCR). On the basis of the results of stage 1, a second population of 141 consecutive patients with steady state mild to moderate chronic bronchitis (FEV(1) >or=50% predicted) was studied. On admission, at regular intervals, and at exacerbation all patients underwent serological testing for C pneumoniae (microimmunofluorescence) and a nested touchdown PCR to detect C pneumoniae DNA was performed on peripheral blood mononuclear cells (PBMCs). Patients were assessed over a 12 month period. Information regarding the previous 12 months was taken from medical records. RESULTS: Chronic colonisation of the sputum with C pneumoniae was significantly associated with lower FEV(1) and greater airway bacterial colonisation. On admission to the stage 2 study, 80 patients were PCR negative and 61 were PCR positive. Over the 2 years a mean (SD) of 1.43 (1.32) acute exacerbations occurred in PCR negative patients and 2.03 (1.21) in PCR positive patients (p<0.01). During the 12 month follow up period 34 PCR positive patients had acute exacerbations and were treated with azithromycin for 6 weeks. Serological evidence of acute C pneumoniae reinfection/reactivation was found in two of the 34 patients. The rate of C pneumoniae DNA clearance from blood following treatment was 29% at follow up. CONCLUSION: Chronic colonisation with C pneumoniae is associated with a higher rate of exacerbations of chronic bronchitis. Long term treatment is required to obtain clearance of the organism from the blood.

Aged↗

Assessment by radionuclide angiography of right and left ventricular function in chronic bronchitis and emphysema.

Non-invasive measurements of right and left ventricular ejection fraction (RVEF, LVEF) by multiple-gated equilibrium radionuclide ventriculography were performed in 18 control subjects, 16 patients with angina pectoris, and 45 patients with hypoxic chronic bronchitis and emphysema. The mean RVEF in the control subjects was 0.62 +/- 0.09 (SD), which was not significantly different from the mean RVEF in the patients with angina (0.60 +/- 0.09), but was significantly higher (p less than 0.01) than the mean value in patients with chronic bronchitis and emphysema (0.45 +/- 0.11). LVEF was not significantly different in the groups studied. There was a significant correlation between LVEF and RVEF only in patients with chronic bronchitis and emphysema (p less than 0.001). Those patients with chronic bronchitis and emphysema who had clinical evidence of cor pulmonale at the time of the study had significantly lower values of RVEF and LVEF (p less than 0.001) than patients with no previous cor pulmonale or those who had had cor pulmonale in the past. There was a significant correlation between RVEF and arterial oxygen (p less than 0.01) and carbon dioxide tensions (p less than 0.05). Reduced RVEF in patients with chronic bronchitis and emphysema may be an early indicator of the development of cor pulmonale and may be useful as a non-invasive method of assessing the effects of therapeutic interventions.

Adult↗

Domestic smoke pollution and chronic bronchitis in a rural community of the Hill Region of Nepal.

An earlier study of chronic bronchitis in a rural community of the Hill Region of Nepal using Medical Research Council criteria showed a high prevalence rate that was more or less equal in the two sexes. Most of the women in the study population are exposed to domestic smoke caused by wood and straw fires used for cooking and heating purposes in the ill ventilated houses without chimneys. Data from 1375 individuals were analysed to determine whether there was any relationship between domestic smoke pollution and chronic bronchitis. Exposure to domestic smoke was assessed according to the average time per day spent near the fireplace. The association between chronic bronchitis and cigarette smoking was confirmed. In female nonsmokers and smokers and past smokers of both sexes crude and age adjusted prevalence rates for chronic bronchitis were significantly associated with increasing exposure to domestic smoke. In the living conditions existing in the rural Hill Region of Nepal domestic smoke pollution is an important contributing factor in the development of chronic bronchitis.

Adult↗

Effects of inhalation of N-formyl-methionyl-leucyl-phenylalanine in the well elderly and in patients with chronic bronchitis.

BACKGROUND: Inhalation of the bacterial peptide N-formyl-methionyl-leucyl-phenylalanine (FMLP) produces bronchoconstriction in normal subjects. FMLP thus has a putative role as a mediator of bronchoconstriction associated with bacterial bronchial infection. METHODS: The effects of FMLP inhalation were examined in ten subjects with a history of chronic bronchitis and ten age matched control subjects. Each subject inhaled FMLP doses from 0.025 to 0.8 mumol to determine the provocative dose of FMLP causing a 20% fall in FEV1(PD20FMLP). FEV1 was recorded every five minutes after the final FMLP inhalation until it had returned to 95% of baseline FEV1 or 60 minutes had elapsed. The time to return to 95% baseline FEV1 was recorded or extrapolated from the recovery curve as an index of rapidity of recovery. Total and differential white cell counts were performed on each subject at baseline and five and 15 minutes after the final FMLP inhalation. RESULTS: The geometric mean PD20 FMLP in the patients with chronic bronchitis was 0.06 mumol (95% confidence interval 0.015-0.26), which was significantly lower than that in the control subjects (0.21 mumol (0.02-1.9)). PD20 FMLP in the patients with chronic bronchitis but not age matched controls (p = 0.35) was lower than that found previously in young normal subjects (0.35 mumol (0.07-1.8). The return to 95% baseline FEV1 occurred after 86(10) minutes in subjects with chronic bronchitis and in 81(23) minutes in their age matched controls, in both cases being much slower than that seen in young subjects (29(9) minutes). CONCLUSION: Patients with chronic bronchitis may be especially susceptible to formyl peptides elaborated by bacteria during bacterial bronchial infection.

Administration, Inhalation↗