A Health-Related Quality-of-Life Comparison of Formoterol (Oxis^®) Turbuhaler^® plus Budesonide (Pulmicort^®) Turbuhaler^® with Budesonide Turbuhaler^® Alone and Noncorticosteroid Treatment in Asthma: A Randomized Clinical Study in Russia

Abstract

Background: In Russia, current therapy for the long-term management of asthma is mainly nonsteroidal. This situation provides the opportunity to evaluate new asthma treatments in a patient cohort with little previous exposure to inhaled corticosteroids. Objectives: To compare the effect of formoterol (Oxis^®) Turbuhaler^® plus budesonide (Pulmicort^®) Turbuhaler with budesonide Turbuhaler alone, on the health-related quality of life (HRQL) of patients with mild to moderate asthma. Methods: A double-blind, parallel-group, randomized, 12-week study compared formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone with an open control group of the investigator’s choice of noncorticosteroid therapy. Patients completed the Short Form 36 (SF-36) and the Asthma Quality of Life Questionnaire (AQLQ). Results: The improvement in HRQL scores for patients treated with noncorticosteroids was significantly less (p < 0.05) than those treated with formoterol plus budesonide and budesonide alone in all domains of the SF-36 and AQLQ with one marginal exception (budesonide versus investigator’s choice, SF-36, Mental Component Scale, p = 0.053). Improvements in HRQL scores of formoterol plus budesonide, compared with budesonide alone, although generally higher, were not significantly different. Formoterol plus budesonide was more effective in improving lung function and reducing both symptoms and the need for relief terbutaline inhalation. Conclusion: Formoterol Turbuhaler plus budesonide Turbuhaler and budesonide Turbuhaler alone significantly improved the HRQL of patients with mild to moderate asthma compared with noncorticosteroid treatment.

The effect of budesonide and formoterol in one pressurized metered-dose inhaler on patient-reported outcomes in adults with mild-to-moderate persistent asthma

“…Patients treated with budesonide/formoterol pMDI experienced significantly greater improvements in AQLQ(S) overall and domain scores compared with patients treated with formoterol DPI or placebo; improvements in these measures with the combination were similar to those with budesonide pMDI, suggesting that the budesonide component is primarily responsible for these improve ments. These findings are similar to those observed in a previous study that demonstrated similar AQLQ(S) scores for patients treated with budesonide plus formoterol via separate inhalers compared with patients treated with budesonide alone in patients with mild-tomoderate asthma 32 . In the present study, budesonide also appeared to be the key component responsible for the improvements observed in symptom variables (i.e., asthma symptoms, symptom-free days, asthma control days, and awakening-free nights) because patients treated with either budesonide/formoterol pMDI or budesonide pMDI alone experienced similar improvements.…”

Addition of Formoterol or Montelukast to Low-Dose Budesonide: An Efficacy Comparison in Short- and Long-Term Asthma Control

“…In our study, we found that the use of low-dose budesonide was sufficient to control inflammation because there was no asthma exacerbation in either group. Similar results were obtained in studies that compared ICS plus long-acting β 2 agonists with ICS alone [9, 26, 36, 37]. It was shown in the Formoterol and Corticosteroids Establishing Therapy study that the addition of formoterol to budesonide treatment decreases severe and mild exacerbation rates down to 63 and 62%, respectively [26].…”

Outcomes associated with inhaled corticosteroid use in asthma and COPD: an update

“…Increase in AQLQ scores from baseline was more for both corticosteroid groups, and were above 0.5 indicating significant clinical improvement. The increase in overall and individual domain scores was higher for combination drugs than in the budesonide group, except for the emotional domain [77].…”

“…Increase in AQLQ scores from baseline was more for both corticosteroid groups, and were above 0.5 indicating significant clinical improvement. The increase in overall as individual domains scores was higher for combination than in budesonide group, except for emotional domain [77] Multicenter, double-blind, randomized study HRQOL (AQLQ scores) Mean improvement in AQLQ scores achieved clinical importance in all four domains of AQLQ in the salmeterol/fluticasone group (mean change equal or greater than 0.5 is of clinical significance), but in only two domains in the budesonide group. Overall, AQLQ scores salmeterol/fluticasone group higher but not significantly different from budesonide [78] Review article HRQOL (AQLQ scores) Improved AQLQ scores having clinical significance with salmeterol/fluticasone combination despite previous treatment with inhaled corticosteroids or β 2 -agonists alone.…”