Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Drugs
Published in: Drugs 17/2006

01-12-2006 | Original Research Article

Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma

A Randomised Clinical Trial

Authors: Dr Michael Noonan, Lanny J. Rosenwasser, Paula Martin, Christopher D. O’Brien, Liza O’Dowd

Published in: Drugs | Issue 17/2006

Login to get access

Abstract

Background: Inhaled corticosteroids (ICSs) are the preferred maintenance therapy for adults and children with mild, moderate and severe persistent asthma, with the addition of a long-acting β2-adrenoceptor agonist to ICS therapy recommended for patients with moderate or severe persistent asthma. The efficacy and safety of the combination of budesonide and formoterol delivered via dry powder inhaler (DPI) is well documented.
Objective: To compare the efficacy and safety of budesonide/formoterol pressurised metered-dose inhaler (budesonide/formoterol pMDI; Symbicort™ pMDI, AstraZeneca LP, Wilmington, DE, USA) with budesonide pMDI (Pulmicort® pMDI, AstraZeneca, Lund, Sweden), formoterol DPI (Oxis® Turbuhaler®, AstraZeneca, Lund, Sweden), budesonide plus formoterol in separate inhalers (budesonide pMDI + formoterol DPI) and placebo.
Study design: This was a 12-week randomised, double-blind, double-dummy, placebo-controlled study.
Setting: This multicentre study was conducted in the respiratory specialty clinical practice setting.
Patients: The study included 596 patients ≥12 years of age with moderate to severe persistent asthma previously receiving ICSs.
Interventions: After 2 weeks on budesonide pMDI 80µg × two inhalations (160μg) twice daily, patients received budesonide/formoterol pMDI 160μg/4.5μg × two inhalations (320μg/9μg); budesonide pMDI 160μg × two inhalations (320μg) + formoterol DPI 4.5μg × two inhalations (9μg); budesonide pMDI 160μg × two inhalations (320μg); formoterol DPI 4.5μg × two inhalations (9μg); or placebo twice daily.
Main outcome measures: There were two prespecified primary efficacy variables: mean change from baseline in morning predose forced expiratory volume in 1 second (FEV1), obtained approximately 12 hours after the most recent administration of study medication at home and immediately before the next administration of study medication at the clinic; and mean change from baseline in 12-hour FEV1, assessed as the average change in FEV1 from serial spirometry over the 12-hour period after administration of the morning dose of study medication at the clinic.
Results: Mean changes from baseline in morning predose FEV1 at end of treatment were greater (p ≤ 0.049) with budesonide/formoterol pMDI (0.19L) versus budesonide pMDI (0.10L), formoterol DPI (−0.12L) and placebo (−0.17L). Mean changes from baseline in 12-hour FEV1 were greater (p ≤ 0.001) with budesonide/formoterol pMDI after 1 day (0.37L), 2 weeks (0.34L) and at end of treatment (0.37L) versus budesonide pMDI (0.11, 0.15 and 0.15L) and placebo (0.09, −0.03 and −0.03L), and after 2 weeks and at end of treatment versus formoterol DPI (0.19 and 0.17L). Fewer (p ≤ 0.025) patients receiving budesonide/formoterol pMDI versus monoproducts or placebo met worsening asthma criteria. Results were similar in the budesonide/formoterol pMDI group and the budesonide pMDI + formoterol DPI group on all measures. All treatments were well tolerated with similar safety profiles.
Conclusions: In this population, twice-daily budesonide/formoterol pMDI provides asthma control significantly greater than the monocomponents or placebo and comparable with budesonide pMDI + formoterol DPI. Safety profiles were similar for all treatments.
Footnotes
1
The use of trade names is for product identification purposes only and does not imply endorsement.
 
Literature
1.
National Asthma Education and Prevention Program. Expert panel report: guidelines for the diagnosis and management of asthma: update on selected topics, 2002. J Allergy Clin Immunol 2002; 110 (5 Suppl.): S141–219CrossRef
2.
Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention: GINA workshop report. Publication no. 02–3659. Bethesda (MD): National Institutes of Health (NIH), 2005
3.
National Asthma Education and Prevention Program. Expert panel report 2: guidelines for the diagnosis and management of asthma. Publication no. 97-4051. Bethesda (MD): National Heart, Lung, and Blood Institute, National Institutes of Health, 1997
4.
Stoloff SW, Stempel DA, Meyer J, et al. Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies. J Allergy Clin Immunol 2004; 113: 245–51PubMedCrossRef
5.
Bender B, Milgrom H, Rand C. Nonadherence in asthmatic patients: is there a solution to the problem? Ann Allergy Asthma Immunol 1997; 79: 177–86PubMedCrossRef
6.
Berger WE. The use of inhaled formoterol in the treatment of asthma. Ann Allergy Asthma Immunol 2006; 97: 24–33PubMedCrossRef
7.
Buhl R. Budesonide/formoterol for the treatment of asthma. Expert Opin Pharmacother 2003; 4: 1393–406PubMedCrossRef
8.
Buhl R, Creemers JP, Vondra V, et al. Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma. Respir Med 2003; 97: 323–30PubMedCrossRef
9.
Lalloo UG, Malolepszy J, Kozma D, et al. Budesonide and formoterol in a single inhaler improves asthma control compared with increasing the dose of corticosteroid in adults with mild-to-moderate asthma. Chest 2003; 123: 1480–7PubMedCrossRef
10.
Zetterström O, Buhl R, Mellem H, et al. Improved asthma control with budesonide/formoterol in a single inhaler, compared with budesonide alone. Eur Respir J 2001; 18: 262–8PubMedCrossRef
11.
Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol therapy: evidence-based guidelines. Chest 2005; 127: 335–71PubMedCrossRef
12.
American Thoracic Society. Standardization of spirometry: 1994 update. Am J Respir Crit Care Med 1995; 152: 1107–36
13.
Pauwels RA, Löfdahl C-G, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med 1997; 337: 1405–11PubMedCrossRef
14.
Baker JW, Mellon M, Wald J, et al. A multiple-dosing, placebo-controlled study of budesonide inhalation suspension given once or twice daily for treatment of persistent asthma in young children and infants. Pediatrics 1999; 103: 414–21PubMedCrossRef
15.
Kemp J, Wanderer AA, Ramsdell J, et al. Rapid onset of control with budesonide Turbuhaler in patients with mild-to-moderate asthma. Ann Allergy Asthma Immunol 1999; 82: 463–71PubMedCrossRef
16.
Metzger WJ, Hampel FC Jr, Sugar M. Once-daily budesonide inhalation powder (Pulmicort Turbuhaler®) is effective and safe in adults previously treated with inhaled corticosteroids. J Asthma 2002; 39: 65–75PubMedCrossRef
17.
Tinkelman DG, Bronsky EA, Gross G, et al. Efficacy and safety of budesonide inhalation powder (Pulmicort Turbuhaler) during 52 weeks of treatment in adults and children with persistent asthma. J Asthma 2003; 40: 225–36PubMedCrossRef
18.
Palmqvist M, Persson G, Lazer L, et al. Inhaled dry-powder formoterol and salmeterol in asthmatic patients: onset of action, duration of effect and potency. Eur Respir J 1997; 10: 2484–9PubMedCrossRef
19.
Boonsawat W, Charoenratanakul S, Pothirat C, et al. Formoterol (OXIS®) Turbuhaler® as a rescue therapy compared with salbutamol pMDI plus spacer in patients with acute severe asthma. Respir Med 2003; 97: 1067–74PubMedCrossRef
20.
Derom EY, Pauwels RA. Time course of bronchodilating effect of inhaled formoterol, a potent and long acting sympathomimetic. Thorax 1992; 47: 30–3PubMedCrossRef
21.
Kesten S, Chapman KR, Broder I, et al. Sustained improvement in asthma with long-term use of formoterol fumarate. Ann Allergy 1992; 69: 415–20PubMed
22.
Steffensen I, Faurschou P, Riska H, et al. Inhaled formoterol dry powder in the treatment of patients with reversible obstructive airway disease: a 3-month, placebo-controlled comparison of the efficacy and safety of formoterol and salbutamol, followed by a 12-month trial with formoterol. Allergy 1995; 50: 657–63PubMedCrossRef
23.
Arvidsson P, Larsson S, Löfdahl CG, et al. Inhaled formoterol during one year in asthma: a comparison with salbutamol. Eur Respir J 1991; 4: 1168–73PubMed
24.
Kozlik-Feldmann R, von Berg A, Berdel D, et al. Long-term effects of formoterol and salbutamol on bronchial hyperreactivity and β-adrenoceptor density on lymphocytes in children with bronchial asthma. Eur J Med Res 1996; 1: 465–70PubMed
25.
Rosenhall L, Elvstrand A, Tilling B, et al. One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort® Turbuhaler®) for the treatment of asthma. Respir Med 2003; 97: 702–8PubMedCrossRef
26.
Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL Study. Am J Respir Crit Care Med 2004; 170: 836–44PubMedCrossRef
27.
Kavuru M, Melamed J, Gross G, et al. Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2000; 105: 1108–16PubMedCrossRef
28.
O’Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al. Low dose inhaled budesonide and formoterol in mild persistent asthma. The OPTIMA randomized trial. Am J Respir Crit Care Med 2001; 164: 1392–7
29.
Shapiro G, Lumry W, Wolfe J, et al. Combined salmeterol 50 μg and fluticasone propionate 250 μg in the Diskus device for the treatment of asthma. Am J Respir Crit Care Med 2000; 161: 527–34PubMed
30.
Wolfe J, LaForce C, Friedman B, et al. Formoterol, 24 μg bid, and serious asthma exacerbations: similar rates compared with formoterol, 12 μg bid, with and without extra doses taken on demand, and placebo. Chest 2006; 129: 27–38PubMedCrossRef
31.
Passalacqua G, Albano M, Canonica GW, et al. Inhaled and nasal corticosteroids: safety aspects. Allergy 2000; 55: 16–33PubMedCrossRef
32.
Metadata
Title
Efficacy and Safety of Budesonide and Formoterol in One Pressurised Metered-Dose Inhaler in Adults and Adolescents with Moderate to Severe Asthma
A Randomised Clinical Trial
Authors
Dr Michael Noonan
Lanny J. Rosenwasser
Paula Martin
Christopher D. O’Brien
Liza O’Dowd
Publication date
01-12-2006
Publisher
Springer International Publishing
Published in
Drugs / Issue 17/2006
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200666170-00006

Other articles of this Issue 17/2006

Drugs 17/2006 Go to the issue

Therapy In Practice

Polycythaemia Vera and Essential Thrombocythaemia

Leading Article

Potential of Aromatase Inhibitors for Ovulation and Superovulation Induction in Infertile Women

Review Article

Current Pharmacological Options for the Management of Primary Hyperparathyroidism

Adis Drug Profile

Sunitinib

Adis Drug Profile

Tacrolimus: In Heart Transplant Recipients

Leading Article

Targeted Anti-Cancer Therapies for Renal Cancer