Chest
Volume 129, Issue 2, February 2006, Pages 246-256
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Original Research
Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial

https://doi.org/10.1378/chest.129.2.246Get rights and content

Study objective

To compare a novel asthma management strategy—budesonide/formoterol in a single inhaler for both maintenance therapy and symptom relief—with a higher dose of budesonide plus as-needed terbutaline.

Methods

This was a 6-month, randomized, double-blind, parallel-group study in patients with mild-to-moderate asthma (n = 697; mean age, 38 years [range, 11 to 79 years]; mean baseline FEV1, 75% of predicted; mean inhaled corticosteroid [ICS] dosage, 348 μg/d). Following a 2-week run-in period, all patients received two blinded, dry powder inhalers, one containing maintenance medication and one containing medication to be used as needed for the relief of symptoms. Patients were randomized to receive either budesonide/formoterol (80 μg/4.5 μg, two inhalations qd) for maintenance plus additional inhalations as needed for symptom relief, or budesonide (160 μg, two inhalations qd) for maintenance medication plus terbutaline (0.4 mg) as needed. The primary efficacy variable was morning peak expiratory flow (PEF).

Results

Patients receiving budesonide/formoterol showed greater improvements in morning PEF than patients receiving budesonide (increases of 34.5 L/min vs 9.5 L/min, respectively; p < 0.001). The risk of having a severe exacerbation (hospitalization/emergency department [ED] treatment, oral steroids for asthma, or a ≥ 30% decrease from baseline in morning PEF on 2 consecutive days) was 54% lower with budesonide/formoterol vs budesonide (p = 0.0011). Budesonide/formoterol patients experienced 90% fewer hospitalizations/ED treatments due to asthma than budesonide patients (1 vs 10, respectively; p = 0.026). The increased efficacy with budesonide/formoterol was achieved with less ICS than was used in the budesonide group (mean dose, 240 μg/d vs 320 μg/d, respectively) and with 77% fewer oral steroid treatment days vs budesonide (114 days vs 498 days, respectively). Both treatments were well tolerated.

Conclusions

Budesonide/formoterol for both maintenance and relief improves asthma control with a lower steroid load compared with a higher dose of budesonide plus terbutaline.

Section snippets

Materials and Methods

This double-blind, randomized, parallel-group, active-controlled study (study No. 0667) was conducted at 77 centers in Argentina, Brazil, China, Denmark, Indonesia, Norway, the Philippines, Spain, and Sweden. The study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulations (each study center received ethical approval of the protocol prior to study commencement). Adult patients and parents/guardians of underage children were

Results

From a total of 919 patients enrolled in the study, 697 patients (270 males) aged 11 to 79 years (mean age, 38 years) were randomized to treatment with either budesonide/formoterol in a single inhaler for both maintenance and relief (n = 355) or double-dose budesonide plus as-needed terbutaline (n = 342). A total of 58 patients discontinued the study: 27 patients in the budesonide/formoterol group (19 because eligibility criteria were not fulfilled, 3 because of adverse events [cramps,

Discussion

This study is the first of its kind in the management of mild-to-moderate asthma demonstrating that asthma control can be improved using budesonide and formoterol in a single inhaler for both maintenance and as-needed relief, without the need for a separate inhaler containing reliever medication. Budesonide/formoterol for both maintenance and relief was more effective than traditional asthma therapy using a higher dose of budesonide alone, as demonstrated by improved lung function, reduction in

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Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

Prof. Rabe has been a consultant, participated in Advisory Board Meetings, and received lecture fees from AstraZeneca, Boehringer, Pfizer, Novartis, AltanaPharma, Merck, Sharp and Dohme, and GlaxoSmithKline. Prof. Pizzichini has received reimbursement from AstraZeneca to participate in the 2004 American Academy of Allergy, Asthma & Immunology and European Respiratory Society meetings, during which results/analyses from the submitted study were presented as posters. Dr. Ställberg has received consultancy fees from AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline. Dr. Ställberg has also received fees for organizing educational meetings and fees for speaking at meetings from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Merck, Sharp and Dohme, Pharmacia, and Schering-Plough. Dr. Romero has received consultancy fees from AstraZeneca. Dr. Lier has received small fees from AstraZeneca during the last 5 years for speaking at local meetings for general practitioners. Dr. Jorup is a full-time employee of AstraZeneca and holds shares in the company.

This study was sponsored by AstraZeneca, Lund, Sweden.

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