The initial evaluation included 6-min walk distance; post-bronchodilator pulmonary function tests; maximal exercise capacity during cycle ergometry while receiving 30% oxygen; echocardiography; radionuclide pharmacologic (dobutamine) cardiac stress testing; arterial blood gas measurement; and lung perfusion scanning. Patients also responded to a battery of general and disease-specific self- administered quality of life scales: the Quality of Well-being (QWB) scale, the Short Form-36, St. George’s Respiratory Questionnaire (SGRQ), and the University of California, San Diego Shortness of Breath Questionnaire. Other collected variables included demographics, medications, and smoking habits (type, debut, duration, amount, quit age). сanadianhealthcaremallinc.com
ARMI News - Part 6
In this study, we sought to separate the confounding effects of smoking behavior on severity of lung disease in African-American and white patients, and examined the association between race and the extent of emphysema in a specific, well-defined patient population: enrollees of the National Emphysema Treatment Trial (NETT). Severity, distribution, and physiologic impact of emphysema were evaluated by a battery of cardiopulmonary function tests, quantitative CT of the chest, and quality of life questionnaires. The results of this study may help in understanding host factors involved in the development of severe emphysema, and may aid in shaping antismoking policies that target African Americans.
The prevalence of COPD is known to be different between African Americans and whites. Murphy et al and Massaro et al were the first to suggest that COPD is a disease of white men rather than African Americans. Large epidemiologic surveys confirmed that COPD is the only smoking-related disease in which the prevalence and mortality are higher in white patients than African-American patients (prevalence, 6.3% vs 3.9% for chronic bronchitis, 3.5% vs 1% for emphysema, and mortality rates of 47/ 100,000 vs 21/100,000; respectively). In addition to smoking, the recent executive summary of the Global Initiative for Chronic Obstructive Lung Disease highlights the role of airway hyperresponsiveness and low socioeconomic status as risk factors for the development of COPD. Interestingly, all three factors are more prevalent in African Americans; paradoxically, COPD is more common in white patients. www.storehealthmall.eu
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Summary
The contribution of bias must be considered when interpreting the results of this study. Two potential sources of bias exist. These are as a result of the study design and in the calculation of the predicted normal values. The trial design has used the baseline FEV1 for many of the calculations described in this article. The baseline FEV1 was used as one of the entry criteria for the study and thereby may have given an erroneously high result as investigators and patients attempted to obtain the best possible value for FEV1 at the baseline visit. Also, the design allowed for concomitant treatment to be administered throughout the study; indeed, by the end of the 3 years of study, 45% of the placebo group had received inhaled oral or systemic corticosteroids. This could minimize any possible treatment differences, and the effect would increase as the study progressed. The second source of bias is in the calculation of predicted normal values, in which prediction equations used are > 30 years old and likely provide predicted normal values that are too low. Therefore, interpreting the absolute levels within the groups is likely not precise; however, the random allocation should allow accurate estimates of treatment differences between groups.
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Recommendation
The decline demonstrated a Gaussian-like distribution in both treatment groups but with fewer patients in the budes-onide group in the tail with a greater loss in FEV1. Thus, 21.4% of patients in the placebo group had a decline in FEV1 a 10% over the 3 years of the study, while 17.7% of patients in the budesonide group had a similar decline. In the placebo group, there was a 1.6% decline in FEV1 during the first 6 weeks; subsequently, there was on average, a decline by 0.4% per year up to the 3-year follow-up. In the budesonide group, there was a 0.3% increase in FEV1 during the first 6 weeks; subsequently, there was on average a decline of 0.7% per year up to the 3-year follow-up. These results suggest that there is an effect of the asthmatic process on airway remodeling that is either resistant to the effects of inhaled corticosteroids or may require a higher dose than was used in this study. in detail
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Comment
A surprising result of this study was that no significant effect was demonstrated in adolescents on prebronchodilator or postbronchodilator FEV1 over the 3 years of the study. This result was similar to that described in the CAMP trial, which contained a large proportion of adolescent children. Features of asthma are known to improve in many asthmatic children during adolescence, which has coined the phrase “growing out of asthma.” This improvement may explain the lack of change in FEV1 in these patients. Alternatively, the prediction equation for the FEV1 was modeled from the predictions in children and adults, which may have reduced the precision to detect change over time. During puberty, the relationship between height and lung function is more complex that at other periods of life, and assessment of FEV1 percentage of predicted may not be as precise a measure as at other ages Also, adherence with treatment is often worse as children age, which may in part explain the lack of effect of budesonide. so
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Conclusion
The prebronchodilator FEV1 value improved in both the placebo- and budesonide-treated populations but significantly more so with budesonide treatment. The beneficial effect of budesonide is consistent with many previous studies demonstrating an improvement in prebronchodilator FEV1 over time with inhaled corticosteroids. The improvement in the placebo-treated group is likely due to the either the benefit that patients achieve from just being enrolled in clinical trials (the Hawthorne effect), or the fact that patients were allowed to be treated with other antiasthma medications, including inhaled or systemic corticosteroids, during the study, at the investigator’s discretion, to achieve asthma control (indeed, by the end of year 1, 21.4% of placebo-treated patients had been administered a nonstudy, inhaled or systemic corticosteroid treatment), or a combination of these two effects. Link
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Discussion
This study is the first large, prospective evaluation of the effects of early intervention with inhaled corticosteroids on asthma progression, as determined by the development of severe asthma-related events and changes in lung function. In this study, average duration of time since asthma diagnosis was < 1 year. The study demonstrated that treatment with low doses of inhaled budesonide improved both prebronchodilator and postbronchodilator FEV1, and this effect persisted over the 3 years of the study. However, despite the benefits of inhaled budes-onide, the postbronchodilator FEV1 declined in both treatment groups over the duration of the study. This article extends the description of the results previously described by focusing only on the effects of early intervention with inhaled corticosteroids on lung function, the distribution of the response, and the factors that may determine the response. website
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Research
The change in postbronchodilator FEV1 in the treatment groups demonstrated a Gaussian-like distribution (Fig 2), and the decline was more marked for males, current, or previous smokers, and patients > 18 years old. In the placebo group over years, the decline in male subjects was — 3.6% and in female subjects was — 1.95%; while in the budesonide group, the decline in male patients was — 2.68% and in female patients was — 1.13%. Similarly, in active smokers in the placebo group, the decline over 3 years was — 4.36% and in nonsmokers was — 2.45%, while in the budesonide group the decline in active smokers was — 2.84% and in nonsmokers was — 1.53%. mycanadianfamilypharmacy.net
Interestingly, the smallest decline in postbronchodilator FEV1 over 3 years was seen in adolescents when compared to children or adults (Fig 3): change from baseline in the placebo group, — 0.39%; change from baseline in the budesonide group, — 0.91%. In addition, the smallest treatment effect of budesonide on postbronchodilator FEV1 was seen in adolescents.
Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Results
Of the 7,241 patients that entered the study, 7,165 were available for analysis, of whom 3,597 were randomized to budesonide and 3,568 to placebo. From this cohort, 2,010 patients did not complete the 3 years of double-blind treatment. The dropout rate (27.5% in the budesonide group and 28.6% in the placebo group) and the mean time in the study (2.47 years in the budesonide group and 2.44 years in the placebo group) were comparable for the two treatment arms. There were 3,419 patients in the budesonide group and 3,394 patients in the placebo group with assessments of postbronchodilator FEV1 at baseline and on at least one follow-up occasion. All these patients are used in the longitudinal analysis of postbronchodilator FEV1. The baseline characteristics were similar in the two treatment groups (Table 1).