Maximum Asthma Control
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European Respiratory Journal Figures Tables Additional Files. Figure 1— Examples of typical individual patterns of exhaled nitric oxide fraction F eNO and peak expiratory flow PEF levels over 2 weeks in a and d healthy, b and e stable controlled and c and f uncontrolled asthmatic subjects.
Figure 2— Diurnal variations of a and c exhaled nitric oxide fraction F eNO and b and d peak expiratory flow PEF levels in healthy and asthmatic subjects according to either asthma severity or asthma control are shown. Figure 3— Daily mean variation of exhaled nitric oxide fraction F eNO levels over 2 weeks according to a asthma control status or b asthma severity. Figure 4— Daily average variation of peak expiratory flow PEF levels over 2 weeks according to a asthma control status or b asthma severity.
Tables Figures Additional Files. Table 1— Exhaled nitric oxide fraction F eNO and peak expiratory flow PEF expressed in different ways in relation to their predictive values for uncontrolled asthma. Table 2— Subject characteristics. Table 3— Asthma control and exacerbations over 3 months follow-up. Table 4— Asthma severity and exacerbations over 3 months follow-up.
Table 5— Diagnostic value of different parameters or combination of markers for predicting uncontrolled asthma. Table 6— Predictors for discriminating uncontrolled asthma from stable controlled asthma using multiple logistic regression analysis.
The correlation between asthma control and health status: the GOAL study
Additional Files Figures Tables. Disclosures Files in this Data Supplement: View this article with LENS. Vol 43 Issue 2 Table of Contents. Thank you for your interest in spreading the word on European Respiratory Society. You are going to email the following Domiciliary diurnal variation of exhaled nitric oxide fraction for asthma control. Domiciliary diurnal variation of exhaled nitric oxide fraction for asthma control.
Subjects Asthma and allergy. The evaluation period for this retrospective analysis was the same in all three studies: This period was selected to ensure that the analysis was performed during the period of maximum plateau effect for all study treatments, and to avoid bias in favour of the groups that received bronchodilators alone or in combination , which would be expected to take effect more quickly than inhaled corticosteroids. Certain thresholds were set for control assessments to determine whether a patient could be included in the retrospective analysis.
If any of these thresholds were not met, data from that patient was classed as missing. The level of control in any given week could only be assessed if all the individual criteria for that week were evaluable.
Achieving guideline-based asthma control: does the patient benefit? | European Respiratory Society
One exception to this was that if one of the group of three criteria PEF, symptoms and rescue salbutamol use was not evaluable, the patient could still be classified as well controlled, as long as there were sufficient data to show that the other two criteria had been met as a patient could fail one of these three criteria in a week and still be classed as well controlled. To be classed as well controlled, patients had to be well controlled in every evaluable week, that is: Patients with 4 weeks of evaluable data who failed to achieve one of these targets were classed as not well controlled.
Furthermore, if patients withdrew from the study because of an asthma exacerbation or a drug-related adverse event, or if the study treatment lacked efficacy, they were classed as not well controlled for the whole 8-week period. Data from patients who withdrew for any other reason were classed as missing. The AQLQ is a disease-specific instrument that has been validated in clinical trials 12 — The AQLQ contains 32 questions items comprising four domains: Each item is scored on a 7-point Likert scale where 1 indicates severe impairment and 7 indicates no impairment.
The overall score is the mean of the 32 items. A change in mean overall or domain score of 0. The AQLQ is a disease-specific questionnaire, so it would not be meaningful to test it in a healthy population in an attempt to define the AQLQ score for a nonasthmatic. Data were analysed to determine control status over the 8-week period and mean overall AQLQ scores at study baseline and endpoint either the end of the treatment period or upon early withdrawal for each evaluable patient.
No missing data were imputed. To examine whether the exclusion of patients for whom control was unevaluable due to missing data affected the results, these patients were included in a repeat analysis using the conservative assumption that they were not well controlled. This analysis was retrospective and no hypothesis was established prior to analysis so only descriptive summary statistics are presented.
The mean and sd of the AQLQ scores at study endpoint and the difference between endpoint and baseline scores were determined for the well-controlled and not well-controlled subgroups of each treatment group. An additional analysis was conducted on the data from study A to compare the composite definition of control, based on GINA guidelines, with control measured by four of the individual clinical parameters that constitute the composite measure of asthma control.
The aim was to see whether control of any one parameter was associated with the overall QOL improvement obtained when composite asthma control was achieved. The numbers of patients in studies A, B and C who provided sufficient data to be evaluable in at least one analysis were , and , respectively. The majority of patients excluded were those that failed to complete the AQLQ adequately. The distribution of patients between the treatment groups was generally even. Well-controlled patients who achieved guideline-based asthma control had consistently higher overall AQLQ scores than the patients who were not well controlled.
Mean AQLQ scores achieved by well-controlled patients at endpoint were largely similar, regardless of treatment intervention or asthma severity, and, with the exception of the budesonide group in study C, approached or exceeded 6. While mean AQLQ scores were similar across treatment groups in well-controlled patients, the number of patients who achieved well-controlled status varied markedly by treatment intervention. The greatest number of well-controlled patients was seen in the SFC group in all three studies, with only a few well-controlled patients in the placebo studies A and B and budesonide study C treatment groups.
Mean scores bars and standard deviation lines shown for all patients and by treatment group. All dosages shown were given twice daily. In patients who were not well controlled, mean overall AQLQ scores were lower than for controlled patients and the AQLQ score achieved at endpoint was dependent on the treatment used. The trends were similar to those seen for overall endpoint scores: This difference was seen consistently within each treatment group in all studies with the exception of budesonide in study C.
As with the overall endpoint AQLQ scores, mean change in AQLQ in the not well-controlled patients was dependent on the treatment group, and the same ranking of score changes was seen: The only patients who recorded clinically important gains irrespective of level of control were those who received SFC. As with the analysis of overall score, the number of patients who achieved control differed between the various treatment groups.
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The association between asthma control and the change in QOL during each study is further illustrated by examining the number of patients who achieved a clinically important improvement in QOL. The results from studies B and C show a similar trend data not shown. All doses shown were given twice daily. The relationships between baseline and endpoint AQLQ scores for all patients in studies A and B were assessed, for each treatment group and by level of control, by plotting the two values on a scatter plot fig. The well-controlled patients showed improvements in AQLQ score, many to near-maximal levels.
In addition, the plots for well-controlled patients also show that near-maximal endpoint AQLQ scores were achieved in patients with a range of baseline scores, in some cases as low as 3—4.
By contrast, the not well-controlled subgroups contained a higher proportion of patients whose endpoint scores were the same as, or less than, their baseline scores. Using the composite measure of control, the difference in AQLQ score changes between well-controlled and not well-controlled patients was relatively large 0. In contrast, when control was assessed according to a single clinical measure, the difference in AQLQ score change between those who achieved control and those who did not was smaller 0. Comparison between composite definition of asthma control and control measured according to a single parameter.
Retrospective analysis of three clinical studies supports the hypothesis that asthma control, as defined by physician-based criteria in asthma management guidelines, is associated with improved QOL as assessed by the patient. Furthermore, these data suggest that well-controlled patients can achieve near-maximal AQLQ scores, representing little or no impact of asthma on their lives. This hypothesis should be prospectively tested in future studies.
The apparent association between the achievement of guideline-based asthma control and better QOL is shown by mean AQLQ scores at study endpoints that are higher in the well-controlled patient subgroups. This was seen consistently across studies, and therefore severities of asthma, suggesting that even in more severe patients, the same asthma control objectives are achievable and that patients with more severe disease do not have to accept less favourable outcomes.
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The improvement in AQLQ score from baseline at endpoint also appears to be greater in well-controlled than not well-controlled patients, which was seen consistently within each treatment group. In the majority of cases, the improvements in QOL in the well-controlled group exceeded the threshold for a clinically important difference.
The present authors also found that patients who recorded low baseline AQLQ scores were more likely to achieve higher, and in some cases near-maximal, endpoint scores if they were well controlled, than those patients who were not well controlled. While well-controlled patients achieved greater improvements in QOL than not well-controlled patients, some differences were observed between treatment groups.
Patients who received SFC experienced clinically important improvements in QOL whether or not they were well controlled.
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This was evident in both the change in AQLQ score and in the number of patients achieving a clinically meaningful improvement in AQLQ, compared with other treatments. This suggests that even if control is not achieved, meaningful improvements in QOL can be obtained with appropriate treatment. The composite definition of control used in this analysis had six components, including measures of disease that would be perceived as important by patients, such as symptom score, bronchodilator usage, night-time waking and exacerbations.
Therefore, at first sight it might be expected that patients who achieve control of their asthma in several ways should experience accompanying benefits in their QOL. However, the definition of control is based on clinical indices and the QOL assessment is based on a patient's perception of benefit. It would be wrong to assume that meeting the needs of the clinician is the same as meeting the needs of the patient.
Indeed, it has been shown that no single conventional clinical measure can capture patient-perceived QOL benefits 5. The results of the present analysis are consistent with other published data in so far as they suggest that if a patient's asthma control improves, their AQLQ scores increase 17 , However, the present analysis is different, and therefore valuable, in two key aspects: The emphasis of the present analysis was not only on improvement in QOL from baseline, but also the attainment of maximal or near-maximal AQLQ scores, suggesting minimal or no impact of asthma on QOL.
Although the current study is a retrospective analysis, the variety of analyses that have been performed provides useful information on the relationship between these two approaches to assessing QOL. More importantly, it supports the view that physicians and patients do not appreciate the extent to which asthma can be completely controlled and patients can enjoy normal QOL.
This relationship, and the assessment of the proportion of asthmatics in which ideal control can be achieved, will require study in prospective trials. The second key aspect of this analysis was the definition of asthma control used. Asthma control was defined using a composite measure that corresponds to the long-term management goals set out by established international treatment guidelines. This analysis therefore attempts to validate the long-term treatment goals of GINA from the patients' perspective. This approach appears to be justified, in that it was shown that there are differences in the degrees of QOL improvement according to whether asthma control is defined using a composite measure or a single measure, such as PEF.
The results of this analysis suggest that if patients achieve guideline-based composite control, they will achieve larger improvements in QOL than if success in only a single measure is achieved. Conversely, failure to achieve good control as measured by a single parameter does not necessarily predict failure in terms of QOL improvements.
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This supports the view that a composite control measure provides a better predictor of likely improvement in quality of life or of likely failure to improve than measurement of single clinical endpoints. An additional important feature of the control definition employed in the present study was that patients were assessed over an 8-week period, during which their asthma was evaluated weekly according to goals set out in the GINA guidelines 3.
However, measuring control over a longer time period than 1 day should give a better picture of how well a patient can both achieve and maintain control. The assessment of longitudinal control with a daily measure is more difficult because a patient's level of control can vary considerably from one day to the next, generating greater variability in the data.
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The decision to use weekly control assessments corresponds more closely to the management goals in the GINA guidelines than measuring control daily, which is the method used in the present authors' previous paper 4. Moreover, from the physician's point of view, a week is a more practical period over which to evaluate asthma control.
This is an important consideration, as any assessment of control must be practical or usable in clinical practice.