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.

1.
Chuchalin AG, Ovcharenko SI, Goriachkina LA, Sidorenko IV, Tsoi AN on behalf of the EPOCH Study Group: The safety and efficacy of formoterol (Oxis®) Turbuhaler® plus budesonide (Pulmicort®) Turbuhaler in mild to moderate asthma: A comparison with budesonide Turbuhaler alone and current non-corticosteroid therapy in Russia. Int J Clin Pract, in press.
2.
Juniper JE: Quality of life in adults and children with asthma and rhinitis. Allergy 1997;52:971–977.
3.
Juniper EF: Quality-of-life considerations in the treatment of asthma. Pharmacoeconomics 1995;8:123–138.
4.
Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–483.
5.
Juniper EF, Guyatt GH, Ferrie PJ, Griffith LE: Measuring quality of life in asthma. Am Rev Respir Dis 1993;147:832–838.
6.
Rowe BH, Oxman AD: Performance of an asthma quality of life questionnaire in an outpatient setting. Am Rev Respir Dis 1993;148:675–681.
7.
Graham DM, Blaiss MS, Bayliss MS, Espindle DM, Ware JE Jr: Impact of changes in asthma severity on health-related quality of life in pediatric and adult asthma patients: Results from the asthma outcomes monitoring system. Allergy Asthma Proc 2000;21:151–158.
8.
National Heart, Lung and Blood Institute: National Institutes of Health World Health Organization. Global Initiative for Asthma. Pocket guide for asthma management. Bethesda, NIH/NHLBI, 1998, publ No 96–3659B.
9.
Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, Lotvall J: Inhaled dry-powder formoterol and salmeterol in asthmatic patients: Onset of action, duration of effect and potency. Eur Respir J 1997;10:2484–2489.
10.
Bartow RA, Brogden RN: Formoterol: An update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs 1998;55:303–322.
11.
Sill V, Bartuschka B, Villiger B, Ortland C, Domej W: Changes in specific airway resistance (sRAW) in moderate asthma after inhalation of formoterol or salmeterol dry powder formulations. Pneumologie 1999;53:4–9.
12.
Ringdal N, Derom E, Wåhlin-Boll E, Pauwels R: Onset and duration of action of single doses of formoterol inhaled via Turbuhaler®. Respir Med 1998;92:1017–1021.
13.
Seberova E, Andersson A: Oxis (formoterol given by Turbuhaler) showed as rapid an onset of action as salbutamol given by a pMDI. Respir Med 2000;94:607–611.
14.
Tattersfield AE, Löfdahl CG, Postma DS, Eivindson A, Schreurs ADG, Rasidakis A, Ekström T: As needed medication in asthma: A randomised trial comparing formoterol, a long-acting β-agonist, with terbutaline. Lancet 2001;357:257–261.
15.
Wallin A, Melander B, Rosenhall L, Sandström T, Wåhlander L: Formoterol, a new long acting beta 2 agonist for inhalation twice daily, compared with salbutamol in the treatment of asthma. Thorax 1990;45:259–261.
16.
Malolepszy J, Böszörményi Nagy G, Selroos O, Larsson P, Brander R: Safety of formoterol Turbuhaler at cumulative dose of 90 μg in patients with acute bronchial obstruction. Eur Respir J, in press.
17.
Tötterman KJ, Huhti L, Sutinen E, Backman R, Pietinalho A, Falck M, Larsson P, Selroos O: Tolerability to high doses of formoterol and terbutaline via Turbuhaler® for 3 days in stable asthmatic patients. Eur Respir J 1998;12:573–579.
18.
Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK: Evaluation of impairment of health related quality of life in asthma: Development of a questionnaire for use in clinical trials. Thorax 1992;47:76–83.
19.
Juniper EF, Guyatt GH, Willan A, Griffith LE: Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994;47:81–87.
20.
Ware JE, Kemp JP, Buchner DA, Singer AE, Nolop KB, Goss TF: The responsiveness of disease-specific and generic health measures to changes in the severity of asthma among adults. Qual Life Res 1998;7:235–244.
21.
Mancuso CA, Peterson MG, Charlson ME: Comparing discriminative validity between a disease-specific and general health scale in patients with moderate asthma. J Clin Epidemiol 2001;54:263–274.
22.
Sullivan M, Karlsson J: The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: Results from normative population. J Clin Epidemiol 1998;51:1105–1113.
23.
Postma DS, Löfdahl CG, Tattersfield A, Ekstrom T, Eivindson A, Rasidakis A, Ståhl E, Karlsson K, Larsson P: Formoterol used on demand improves quality of life in patients with asthma. Am J Respir Crit Care Med 1999;159:A760.
24.
Juniper EF, Svensson K, O’Byrne PM, Barnes PJ, Bauer C-A, Löfdahl C-GA, Postma DS, Pauwels RA, Tattersfield AE, Ullman A: Asthma quality of life during 1 year with budesonide with or without formoterol. Eur Respir J 1999;14:1038–1043.
25.
Busse WW, Casale TB, Murray JJ, Petrocella V, Cox F, Rickard K: Efficacy, safety, and impact on quality of life of salmeterol in patients with moderate persistent asthma. Am J Manag Care 1998;4:1579–1587.
26.
Kemp JP, Cook DA, Incaudo GA, Corren J, Kalberg C, Emmett A, Cox FM, Rickard K: Salmeterol improves quality of life in patients with asthma requiring inhaled corticosteroids. Salmeterol Quality of Life Study Group. J Allergy Clin Immunol 1998;101:188–195.
27.
Lockey RF, DuBuske LM, Friedman B, Petrocella V, Cox F, Rickard K: Nocturnal asthma: Effect of salmeterol on quality of life and clinical outcomes. Chest 1999;115:666–673.
28.
Wenzel SE, Lumry W, Manning M, Kalberg C, Cox F, Emmett A, Rickard K: Efficacy, safety, and effects on quality of life of salmeterol versus albuterol in patients with mild to moderate persistent asthma. Ann Allergy Asthma Immunol 1998;80:463–470.
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