The Influence of an Inhaled Steroid on Quality of Life in Patients With Asthma or COPD

doi:10.1378/chest.107.5.1199

Chest

Volume 107, Issue 5, May 1995, Pages 1199-1205

https://doi.org/10.1378/chest.107.5.1199 Get rights and content

Relatively little is known about the influence of inhaled corticosteroids on general well-being (quality of life) in patients with asthma or COPD. In a 4-year prospective controlled study, we examined the influence of beclomethasone dipropionate (BDP), 400 μg, two times daily, on quality of life in 56 patients with asthma or COPD in comparison with the effects of BDP on symptoms and lung function. During the first 2 years, patients received only bronchodilator therapy with salbutamol or ipratropium bromide. During the third and fourth years, additional treatment with BDP was given. Fifty-six patients (28 with asthma, 28 with COPD) with an annual decline in the forced expiratory volume in 1 s (FEV₁) of at least 80 mL/yr in combination with at least two exacerbations per year during bronchodilator therapy alone participated. Quality of life was assessed at the start and after 2 and 4 years by means of the Inventory of Subjective Health (ISH) and the Nottingham Health Profile (NHP). Although BDP significantly improved the course of lung function (FEV₁) (p<0.0001), it did not improve the ISH score or the six dimensions of the NHP neither in asthma nor in COPD. Beclomethasone dipropionate temporarily decreased respiratory symptoms during months 4 to 6 of BDP treatment in patients with asthma (p<0.01) and during months 7 to 12 in patients with COPD (p<0.05). A weak correlation was found both cross-sectionally and longitudinally between (change in) symptoms and quality of life on the one hand, and the (change in) FEV₁ on the other. It was concluded that BDP did not improve the general well-being of patients with asthma or COPD as measured by these generic health instruments. However, BDP significantly improved the course of lung function and temporarily decreased the severity of symptoms. It seems probable that changes in quality of life would have been better detected by use of a disease-specific health instrument. Such an instrument was not available at the start of the study. Another possible explanation for these observations is that patients soon get used to different levels of lung function and learn to live with their disease. It is advised that disease-specific health instruments are used in future intervention studies and that quality of life is measured frequently during the early phase of the intervention, eg, once every month.

Section snippets

Patients

Fifty-six patients (28 with asthma, 28 with COPD) with an annual decline in FEV₁ of at least 80 mL/yr in combination with at least two exacerbations per year participated in this 4-year study.²² The criteria for diagnosis of asthma or COPD were based on the standards of the American Thoracic Society.^18,²² The study was approved by the Medical Ethics Committee of the University of Nijmegen. All patients gave informed consent.

Study Design and Treatment

At the start of the 4-year intervention study, the patients were

Baseline Characteristics

At the start of the 4-year study, asthmatics were characterized by less past and current smoking, a higher percentage of allergy, a higher reversibility, and a more severe bronchial hyperresponsiveness than patients with COPD (Table 1). Quality of life as assessed by the ISH score was worse in patients with COPD than in patients with asthma (Table 1).

Of the 56 patients, 48 completed treatment with BDP. Reasons for dropping out were as follows: refusal to use corticosteroids (one with asthma,

Discussion

The most important observation of this study was that BDP significantly improved the course of lung function, while there was no evidence that the quality of life measured by generic instruments was changed. BDP diminished the severity of symptoms only significantly for some months during the first year of BDP treatment. During the rest of the treatment period, no influence on symptoms was found either in the weekly recorded symptom score or in the 2-yearly measured MRC symptom score. The

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Multidimensional analyses of long-term clinical courses of asthma and chronic obstructive pulmonary disease
2010, Allergology International
Asthma and chronic obstructive pulmonary disease (COPD) are chronic respiratory disorders involving obstructive airway defects. There have been many discussions on their similarities and differences. Although airflow limitation expressed as forced expiratory volume in one second (FEV1) has been considered to be the main diagnostic assessment in both diseases, it does not reflect the functional impairment imparted to the patients by these diseases. Therefore, multidimensional approaches using multiple measurements in assessing disease control or severity have been recommended, and multiple endpoints in addition to FEV1 have been set recently in clinical trials so as not to miss the overall effects. In particular, as improving symptoms and health status as well as pulmonary function are important goals in the management of asthma and COPD, some patient-reported measurements such as health-related quality of life or dyspnea should be included. Nonetheless, there have been few reviews on the long-term clinical course comparing asthma and COPD as predicted by measurements other than airflow limitation. Here, we therefore analyzed and compared longitudinal changes in both physiological measurements and patient-reported measurements in asthma and COPD. Although both diseases showed similar long-term progressive airflow limitation similarly despite guideline-based therapies, disease progression was different in asthma and COPD. In asthma, patient-reported assessments of health status, disability and psychological status remained clinically stable over time, in contrast to the significant deterioration of these parameters in COPD. Thus, because a single measurement of airflow limitation is insufficient to monitor these diseases, multidimensional analyses are important not only for disease control but also for understanding disease progression in asthma and COPD.
Patient-reported outcomes in adults with moderate to severe asthma after use of budesonide and formoterol administered via 1 pressurized metered-dose inhaler
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Citation Excerpt :
A lack of correlation often exists between PROs and objective measures of pulmonary function in asthma studies.3-5 Therefore, PROs are important measures that supplement physiologic and clinical assessments of asthma.3,6-9 This article reports the effects of budesonide/formoterol pressurized metered-dose inhaler (pMDI; Symbicort Inhalation Aerosol, AstraZeneca, Wilmington, Delaware), budesonide pMDI (Pulmicort pMDI; AstraZeneca, Lund, Sweden) + formoterol dry powder inhaler (DPI) (Oxis Turbuhaler; AstraZeneca) in separate inhalers, budesonide pMDI, formoterol DPI, and placebo, all delivered twice daily, on PROs in patients with moderate to severe persistent asthma.
Patient-reported outcomes (PROs) are important for evaluating asthma therapy.
To evaluate PROs in adults with moderate to severe persistent asthma receiving budesonide and formoterol administered via 1 pressurized metered-dose inhaler (pMDI).
This 12-week, double-blind, double-dummy, placebo-controlled, multicenter study randomized 596 patients 12 years or older to budesonide/formoterol pMDI 160/4.5 μg × 2 inhalations (320/9 μg); budesonide pMDI 160 μg × 2 inhalations (320 μg) + formoterol dry powder inhaler (DPI) 4.5 μg × 2 inhalations (9 μg); budesonide pMDI 160 μg × 2 inhalations (320 μg); formoterol DPI 4.5 μg × 2 inhalations (9 μg); or placebo, each twice daily, after 2 weeks of budesonide pMDI 80 μg × 2 inhalations (160 μg) twice daily. PROs were assessed in 553 patients 18 years or older using the standardized Asthma Quality of Life Questionnaire (AQLQ[S]), Medical Outcomes Survey (MOS) Sleep Scale, Patient Satisfaction With Asthma Medication (PSAM) questionnaire, diary data, and global assessments.
Patients receiving budesonide/formoterol reported significantly greater improvements from baseline on the AQLQ(S) and asthma control variables (based on symptoms and rescue medication use; all P < .001) vs placebo. Clinically important improvements (increase of ≥0.5 points) from baseline to end of treatment in AQLQ(S) overall scores were achieved by 43.6% of patients receiving budesonide/formoterol vs 22.6% of patients receiving placebo (P = .001). The MOS Sleep Scale scores generally showed no differences among treatment groups. Patients receiving budesonide/formoterol had significantly greater PSAM questionnaire scores and better outcomes on physician-patient global assessments at end of treatment vs placebo (all P ≤ .001).
Significantly greater improvements in health-related quality of life and asthma control and greater treatment satisfaction were observed with budesonide/formoterol pMDI vs placebo.
Asthma and health-related quality of life
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The health-related quality of life (HRQoL) is assessed using instruments that have been validated scientifically. From the viewpoint of assessment, they are different from other clinical indices because the subjects themselves evaluate their own HRQoL (the patients in many clinical settings). As an index for evaluating health care services or outcomes, the HRQoL is as important as life expectancy. These instruments can be classified into generic and disease-specific instruments. There are numerous disease-specific instruments that can be used for patients with asthma, such as Juniper et al.'s Asthma Quality of Life Questionnaire (AQLQ), the Living with Asthma Questionnaire (LWAQ), the St. George's Respiratory Questionnaire (SGRQ), and Marks et al.'s Asthma Quality of Life Questionnaire (AQLQ). The characteristics of each instrument should be considered in the selection of specific HRQoL questionnaires for clinical research. Generally, the HRQoL is more disturbed in patients with severe asthma, and has been considered to be an important end-point in randomized controlled trials that involve asthma patients. We expect that further studies will also be performed in Japan.
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Chest

Clinical Investigations: COPDThe Influence of an Inhaled Steroid on Quality of Life in Patients With Asthma or COPD

Section snippets

Patients

Study Design and Treatment

Baseline Characteristics

Discussion

J Allergy Clin Immunol

J Allergy Clin Immunol

Chest

Chest

Soc Sci Med

J Clin Epidemiol

Soc Sci Med

Chest

A comparison of bronchodilator therapy with or without inhaled corticosteroid therapy for obstructive airways disease

N Engl J Med

Corticosteroid trials in non-asthmatic chronic airflow obstruction: a comparison of oral prednisolone and inhaled beclomethasone dipropionate

Thorax

Moderately severe chronic airflow limitation: can corticosteroids slow down obstruction

Eur Respir J

Mucosal inflammation in asthma

Am Rev Respir Dis

The roles of inflammatory cells in the pathogenesis of asthma and of COPD

Am Rev Respir Dis

Effects of long-term treatment with inhaled cromoglycate and budesonide on bronchial hyperresponsiveness in patients with allergic asthma

Eur Respir J

The long-term effects of nedocromil sodium and beclomethasone dipropionate on bronchial responsiveness to methacholine in nonatopic asthmatic subjects

Am Rev Respir Dis

Comparison of a beta2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma

N Engl J Med

Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma in nonsteroid-dependent asthmatics

Am Rev Respir Dis

Effect of therapy on bronchial hyperresponsiveness in the long-term management of asthma

Clin Allergy

Inhaled corticosteroids in COPD: awaiting controlled trials [editorial]

Thorax

Measuring quality of life in asthma

Am Rev Respir Dis

Quality of life measurements for patients with diseases of the airways

Thorax

Clinical Investigations: COPD
The Influence of an Inhaled Steroid on Quality of Life in Patients With Asthma or COPD

Comparison of a beta₂-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma